Unilife Corporation (NASDAQ: UNIS; ASX; UNS)

Unilife Corporation (NASDAQ: UNIS; ASX; UNS) is a U.S. based medical device company began trading on NASDAQ on February 16, 2010, and it continues to trade on the Australian Stock Exchange. The CEO is Alan Shortall. Unilife designs, develops, manufactures, and supplies a proprietary range of retractable syringes, with a customer list includes pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. Unilife’s syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is a emerging global leader for innovative safety medical devices and the Company’s Unifill syringe product is the world’s only prefilled syringe with fully integrated safety features. Unifill is a disruptive technology in markets being driven by legislation and lawsuits.

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Safety Syringe Technology

The Unifill™syringe is targeted for use by pharmaceutical manufacturers who utilize prefilled (ready-to-fill) syringes as a preferred drug delivery device for injectable drugs and vaccines. Today, there are more than 50 drug products used within healthcare facilities or by patients who self-administer prescription medication that are currently available in a prefilled syringe format. Unilife has designed the Unifill syringe so that it is compatible with the drug validation and manufacturing systems currently used by target pharmaceutical customers to fill and package standard prefilled syringes. The Unifill syringe is the only known product of its kind with automatic safety features which are integrated inside the glass barrel. The compact size, intuitive use, functionality and automatic safety features of the Unifill syringe potentially help pharmaceutical companies extend product lifecycles, increase levels of market differentiation in competitive therapeutic areas, and expand the marketability of some drugs for convenient self-administration by patients outside of the healthcare setting.

On a personal note, the writer has an Autistic son and we went through a period of roughly a year where we were giving him vitamin B-12 shots. I personally recognize the cost, safety, and logistics hassles of traditional syringes versus the convenience and cost savings of Unifill.

Sanofi-aventis Agreement

Sanofi is the world’s largest purchaser of prefilled syringes, and is one of the world leaders in the pharmaceutical industry, ranking number one in Europe and number four worldwide. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Unilife and sanofi-aventis have entered into an exclusive five year agreement for the Unifill ready-to-fill syringe. Sanofi-aventis paid $40 million in total for the exclusive right to purchase the Unifill syringe for the therapeutic drug classes of antithrombotic agents and vaccines. The agreement runs till June 30, 2014, and two of sanofi’s therapeutic classes represent the majority of all prefilled syringes consumed globally. Sanofi-aventis also has exclusivity in an additional six smaller sub-groups that fall within other therapeutic classes that Unilife believes represent new market opportunities in the pharmaceutical use of prefilled syringes. Sanofi-aventis also has a ten year extension in June 2014. In the event that sanofi-aventis does not reach certain minimums, terms will be adjusted to the favor of Unilife. Currently Sanofi does roughly 700 million units per year, which is 40% of the therapeutic drug categories defined in the agreement. The current market overall is estimated at $1.5 billion and growing at a 15-20% annual rate.

Now on first read of the sanofi agreement, I viewed this as potentially a safe but market limiting agreement. Unilife CEO Alan Shortall reversed my thought process when he stated "The confined nature of the therapeutic sectors defined within the Exclusivity List considerably EXPANDS our commercial opportunities with additional pharmaceutical companies. In return, sanofi-aventis retains the opportunity to nominate the placement of additional therapeutic drugs onto the Exclusivity list provided they are commercially favorable and do not infringe upon any future agreements we may sign with other pharmaceutical companies."

While the Company has not released per unit prices for the syringes in the contract, market prices are expected to be $0.80-0.85 per syringe. Just taking the two therapeutic classes at minimums of 20 million units each, the Company is looking at revenues of $16+ million for each of the two therapeutics. Unilife is building capacity at the new plant to be 400 million units in 2014 and 1.0 billion units in 2016. Clearly Unilife is expecting to surpass the minimums in the sanofi contract.

March 23, 2010 Conference Call on Unilife’s 12/31/09 Financial Results

Unilife had a conference call with investors and analyst where they reviewed the financial results for its six months ended December 31, 2009.

Net revenues for the six months ended December 31, 2009 were $6.4 million, compared to $8.1 million for the same period in 2008. The Company's net loss for the six months ended December 31, 2009 was $(8.0) million, or $(0.19) per diluted share, as compared to a net loss of $(2.5) million, or $(0.07) per diluted share, for the same period in 2008. Adjusted net loss for the six months ended December 31, 2009, which excludes approximately $4.0 million in share-based compensation expense, depreciation and amortization and certain non-recurring costs associated with the redomiciliation and Nasdaq listing was $(4.0) million, or $(0.10) per diluted share. As of December 31, 2009, the Company's cash and cash equivalents was $41.4 million, assets were $73.1 million, and equity was $57.5 million.

While the 6 month numbers were down for Unilife, this was partially due to early payments by sanofi in late 2008 and early 2009 as the Unilife’s building schedule was ahead of time. 2009 was a significant year for the Company in positioning for the future. The Company’s 2009-10 highlights include:

• Completed an equity raise of $47.1 million in November 2009;
• Successfully redomiciled to the U.S. and listed on the NASDAQ Global Market in February 2010;
• Signed agreement with minimums with sanofi-aventis for Unifill syringes;
• Started commercial manufacturing of Unitract 1mL safety syringes;
• Donated first shipment of Unitract(TM) 1mL safety syringes to the Haiti relief effort
• Signed exclusive five-year agreement with Stason Pharmaceuticals for the Unitract 1mL syringe in Japan, China, and Taiwan. Stason committed to immediately placing an initial commercial order for one million units of the Unitract(TM) 1mL safety syringe.

Update - Manufacturing Plant in York, Pennsylvania

Construction is progressing according to schedule with the external walls and roof of the main section of the building now in place. This 165,000sf, state of the art facility is scheduled to be completed in late 2010, and the initial line will have a 60,000 unit per year capacity. Sanofi-aventis has paid Unilife a €10 million exclusivity fee and committed to pay the Company up to an additional €17 million ($40 million based on exchange rates at the time of the agreement) to fund the industrialization program for the Unifill syringe. Upon the scheduled completion of the industrialization program in late 2010, Unilife expects to commence the supply and sale of the Unifill syringe to sanofi-aventis.

Investment Thesis

• Unilife is in a very strong position, and the Company has targeted these milestones for calendar 2010;
• Continued global rollout of Unitract 1mL Syringes, including additional agreements with additional pharmaceutical companies;
• Expantion of U.S. corporate presence;
• Secure significant market share for Unifill syringe, including a full Unitract™ portfolio of syringes;
• Continue development of additional pipeline products;
• Creating greater awareness across U.S. financial markets.

Update on Tuesday, May 18, 2010 at 11:19AM by Michael W Sweeney

Unilife Corporation (Nasdaq: UNIS) - Third Quarter Fiscal 2010 (3/31/10) Earnings

Summary and Update

In the third fiscal quarter of this year revenues for UNIS were $2.4 million compared to $4.1 million in 2009. Right now, UNIS is not producing significant product revenues as most of their revenues were generated by March payments from the previously reported Sanofi-Aventis deal. In recognition that UNIS’ industrialization program was 12 months ahead of schedule, Sanofi-Aventis agreed to accelerate the agreed-upon quarterly payments. Reality is UNIS is 12 months ahead of schedule toward being a product revenue company.

The net loss was $12.1 million or $0.23 per diluted share. That included roughly $7.0 million of a number of non-recurring and/or non-cash items, including share-based compensation expense, the cost associated with the NASDAQ listing, and $4.3 million for compensation to the inventors of the Unifill patents.

The adjusted net loss is $5.1 million with cash reserves of $24 million.

Highlights covered on the call by CEO Alan Shortall include:

• Stason - The agreement with Stason Pharmaceutical includes a requirement for Stason to purchase a minimum of one million units of the Unitract 1mL syringe per year during the term of the contract (subject to annual review). Stason is placing an immediate annual order with Unilife for the purchase of one million units of the Unitract 1mL syringe. Other countries within South-East Asia (Japan, China and Taiwan) may be added to the list of designated territories where Stason has exclusive rights to sell the product if the parties reach agreement on minimum orders for those countries;
• The Unitract 1mL Syringe got FDA clearance and the 1mL Unitract Syringe will be produced in York, PA FDA registered manufacturing facilities here in the United States. UNIS has employed an additional 60 people since January 2010 as UNIS continues to build the operational infrastructure;
• The York, PA construction continues on schedule;
• The global launch plan for Unitract is being formulated by UNIS management. Shortall stated, “We have an enormous amount of interest in that product and we are reviewing the potential distribution at the moment.” Interest includes pharmaceutical companies in Asia, Europe and the U.S.;
• One potential distributor in the U.S. has the Unitract units in six different hospitals. One of those hospitals is a children’s hospital that currently refuses to use safety syringes because they previously believed the current generation of safety syringes put healthcare workers at risk;
• India – UNIS entered the Indian market last quarter. Dr. Gerald Verollet has worked with Unilife from last six years, and he has recently relocated to India to work with Unilife distributors in India. Dr. Verollet was the former Head of the Medical Device Department in the World Health Organization and was the instigator for writing the current international standards for safety syringes.
• Mary Kate Wold was appointed to Unilife’s Board of Directors. She was with Wyeth for eight years until Pfizer purchased Wyeth last year for $68 billion. Mary Kate was the Senior Vice President of Finance and Treasury at Wyeth, and she was previously a partner at Shearman & Sterling. Wold will chair a new committee focusing on strategic partnerships and pharmaceutical relationships.

Sales in the Pipeline

The Unitract product has an increased level of interest lately, and CEO Shortall stated, “it’s a brilliant product”. At full production levels, Unitract can contribute $10 million of revenue. Shortall predicted that “in the third quarter this year we will start to see revenues coming in. But next year is the big one where we start to see revenues coming in.”



Update on Wednesday, July 21, 2010 at 10:12PM by Michael W Sweeney

Unilife Corporation Update (Nasdaq: UNIS, ASX: UNS) – July 21, 2010

Since my last update on May 18, 2010, there have been a number of significant milestones reached at Unilife. Unilife Corporation’s CEO is Alan Shortall, and the Company is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. In the last two months Unilife has:

• Signed an exclusivity list with sanofi-aventis;
• Management has indicated that there have been “accelerating discussions with other pharmaceutical companies”;
• Alan Shorthall’s management team continues to expand with Rich Wieland joining as CFO and Christopher Naftzger

Russell 3000®, Russell Microcap® and Russell Global® Indexes 

Unilife was added to the Russell 3000®, Russell Microcap® and Russell Global® indexes in the U.S. as of Friday, June 25, 2010. This was very significant for Unilife as they move to a more balanced institutional and retail shareholder base. Many institutional funds have limitations on who they can invest in. Inclusion on the Russell indexes opens up the institutional market for Unilife.

The Russell 3000® Index is comprised principally of the 3,000 largest and most liquid stocks based and traded in the U.S. Russell determines membership for its equity indexes primarily by objective, market-capitalization rankings and style attributes. Membership in the Russell indexes remains in place for one year. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. An industry-leading US$3.9 trillion in assets currently are benchmarked to the Russell indexes. These investment tools originated from Russell's multi-manager investment business in the early 1980s when the company saw the need for a more objective, market-driven set of benchmarks in order to evaluate outside investment managers.

Seeking Alpha – Doug Landy

An independent colleague of mine Doug Landy at Seeking Alpha wrote a very interesting and informative update on Unilife’s “Potential Milestones.” His list of achieved and potential milestones includes:

Potential Milestones for Unilife

• Unilife expects to complete construction of the York, Pennsylvania, facility in late 2010.
• Unilife aims to employ approximately 200 individuals by the end of 2010.
• The industrialization program with Sanofi-Aventis is on track to be completed one year ahead of schedule (late 2010). Supply of the Unifill Syringe to Sanofi-Aventis could begin upon the completion of the industrialization program, with a high-volume automated assembly system is expected to be established by the end of 2011.
• During 2010, Unilife expects to begin to formalize additional relationships with a number of other pharmaceutical companies that wish to use the Unifill Syringe in areas not designated as exclusive to Sanofi-Aventis.
• Unilife intends to begin full commercial supply of its Unitract 1ml Syringe during the first half of 2010 and to secure further distribution agreements for this line of syringes in the U.S. and overseas.

Management

Alan Shortall and Unilife continue to expand their management team. Christopher Naftzger joined as General Counsel, Corporate Secretary and Chief Compliance Officer, and he will provide the management team and Board of Directors of Unilife with counsel on all international, legal and government matters as well as corporate finance and SEC regulation. Prior to joining Unilife, Naftzger served on the senior management team as assistant general counsel and assistant secretary of Chesapeake Corporation, a global supplier of packaging to the pharmaceutical, healthcare and consumer industries. Naftzger has also served as the senior counsel at Koch Industries, Inc, the second largest privately held company in the U.S. with revenues of approximately $98 billion in 2008, and as a partner at Blank Rome LLP, a full service international law and government affairs firm. He holds a juris doctorate from Willamette University College of Law in Oregon, and a bachelor's degree from Hampden-Sydney College in Virginia.

Richard Wieland II joined as Unilife’s Executive Vice President and Chief Financial Officer (CFO). Wieland will oversee the management of Unilife's finance and accounting, human resources and IT operations. Wieland has over 30 years of senior financial experience with U.S.-based public and private companies. He has served as the CFO of four NASDAQ-listed companies within the life sciences industry, and as a senior executive of two New York Stock Exchange-listed companies. Most recently, Mr. Wieland served as the CFO of Cytochroma Inc., a privately-held specialty pharmaceutical company. From 2004 to 2008, Mr. Wieland served as Executive Vice-President and CFO of Advanced Life Sciences Holdings, Inc., a NASDAQ-listed clinical-stage biopharmaceutical company. Prior to that, Mr. Wieland served as a senior executive of other NASDAQ-listed life science and healthcare companies, including Option Care, Inc., where he was a Board member, President and Chief Operating Offer. Wieland received his MBA from Washington University in St. Louis, MO, and his BA in Accounting and Economics from Monmouth College in Monmouth, IL, where he later served as a member of the Board of Trustees. Mr. Wieland is a past member of the National Investor Relations Institute, Financial Executives International and the U.S. Army Signal Corps.

Update on Wednesday, January 12, 2011 at 1:29PM by Michael W Sweeney

Unilife's York, Pennsylvania Facility

Full Article on York Facility

Update on Tuesday, April 5, 2011 at 2:01PM by Michael W Sweeney

$UNIS Unilife Corp.
 
Unilife Corp. (NASDAQ: UNIS; Stock Twits: $UNIS) is a US-based medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injected bio-pharmaceutical products, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices. The key differentiating features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes include: (1) a passive needle retraction system that is activated inside the body; (2) the ability of healthcare providers to control the speed of needle retraction; and (3) an auto-disabling feature that prevents re-use or tampering with used syringes.
 
Earlier today, UNIS announced a corporate realignment to prepare for the upcoming full production and commercialization (Unifill prefilled syringe and Unitract 1mL syringe) at its new manufacturing facilities in Central Pennsylvania (York, PA), which is also projected to result in cost savings that exceed $12 million (M) during calendar year 2011.
 
UNIS currently has approximately 63.5M shares of common stock outstanding for a market cap of about $350M and ended 2010 with $41.5M in cash. In mid to late March, a pair of major open market buys of the Company’s stock were reported and included approximately $250,000 in buying from the COO and $500,000 in buying from the CEO.
 
UNIS has ongoing discussions with 20 bio-pharmaceutical companies for the potential use of the Company’s prefilled safety syringes for use with injected drugs and vaccine products. Sanofi-Aventis (NYSE:SNY) is the Company’s first major customer – paying $40M for the exclusive rights to the Unifill prefilled syringe for a few classes of bio-pharmaceutical products.
 
During 2Q11, UNIS expects to complete the validation process for manufacturing of the Unifill prefilled syringe and to begin initial sales to SNY shortly thereafter. Additional agreements for the Unifill syringe and other products are expected later in 2011 with other bio-pharmaceutical companies. In addition, regulatory approvals are expected to expand the sales through business partners in other countries such as India, Japan, and China.
 
For the six months ended 12/31/10, UNIS reported revenue of $5.3M and had a net loss of $17.6M -- however, the near to intermediate term catalysts outlined above offer the potential for multiple positive catalysts for the stock price and much improved operating financial results as evidence by executive management confidence and open market purchases of the stock last month.

Update on Friday, May 20, 2011 at 4:28AM by Michael W Sweeney

“A tectonic shift is taking place in medicine…” - Personalized Medicine Coalition

"Genentech ... Pushing Data on Personalized Cancer Medicine" - xconomy.com

"Is Business Intelligence The Key To Personalized Medicine?" - InformationWeek - Healthcare

Wake Forest leukemia research suggests personalized approach to chemo - MEDCITY News

Above is a small sample of the headlines in healthcare today. "Personalized Medicine" is being driven by the changes in the healthcare market.

Traditionally, prescription medications have been developed under a one size fits all philosophy. This approach is very inefficient, with half of all patients not responding to medication. Pharmaceutical and biotechnology companies are now looking to pioneer a new generation of medicines that are personalized to the specific needs of the individual patient. This is increasingly known as personalized medicine.

Personalized medication can make pharma companies more productive and profitable. Traditionally, pharma pipelines have been loaded with countless drug candidates in the hope that one can make its way to blockbuster status, and compensate for the losses of those drugs that don’t make it to approval and/or profitability. Pharma companies are now improving their productivity by investing in more personalized (read smaller patient population) therapies that each have a greater likelihood of success and profitability.

As defined by the President’s Council of Advisors on Science and Technology (PCAST):

“Personalized Medicine” refers to the tailoring of medical treatment to the individual characteristics of each patient…to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventative or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not."

PCAST as well as the Personalized Medicine Coalition’s 2009 report create opportunities for pharmaceutical companies developing specialized medicines, such as novel biologics with large molecular compositions. As such drugs cannot be ingested and instead require injection, this also creates opportunities for medical device companies able to design and develop the next generation of drug delivery devices that can safely administer these specialized drugs to the target patient.

A key future emerging trend for drug delivery devices lies with emerging drug delivery device companies that have the right balance between size and agility to collaborate with pharmaceutical companies in the development of next generation drug delivery devices. One such example of an innovative drug delivery device company is Unilife Corporation (NASDAQ: UNIS; Stock Twits: $UNIS), which is at the tail-end of a $40MM industrialization program to commercialize the Unifill syringe. The development of the Unifill syringe serves as a model of how the next wave of drug delivery devices will be brought to market. Sanofi-aventis came to Unilife with a challenge…to integrate safety features into the glass barrel of a prefilled syringe…something that most people thought impossible. After developing early prototypes of the Unifill syringe that proved it was indeed possible, the two parties entered into a collaboration to bring the product to market. The industrialization program was largely funded by sanofi-aventis, with Unilife required to attain stringent project milestones each quarter to receive payment…a model that kept both parties focused on delivery. Unilife has now started production, and will soon begin selling the Unifill syringe to sanofi-aventis, as well as other pharmaceutical companies that are active in non-competitive therapeutic classes.

Having completed the industrialization program for such a complicated device fully on-schedule, Unilife now has the proven track-record that shows it can deliver. Furthermore, it has a new state-of-the-art facility in Pennsylvania that would not have been possible to develop without having a strong collaboration with a major pharmaceutical partner. As a result, Unilife now has the expertise, reputation and capabilities to serve as a a one-stop shop for device innovation. Furthermore, the company is not too large to be bogged down with red-tape and chronic operational overheads. Instead, Unilife is positioned to serve as an agile, highly responsive partner to pharmaceutical companies in developing customized devices from the ground up. The opportunity for Unilife to play a role in collaborating with pharmaceutical companies to develop the next generation of drug delivery devices was recently put forward by CEO Alan Shortall on its third quarter earnings call.

A further aspect of the opportunity facing Unilife is summed up in the phrase, “Not everyone can or should try to do everything.” Drug companies are just that - drug companies. They’re best at research and development of new drugs.  Designing and developing devices to deliver a new drug is a distraction from their core competency. It makes far more sense for drug companies to rely on a supplier who is focused in the area of drug delivery systems.

In the grand scheme, personalized medicine should help drug makers improve their productivity and bottom line by investing in more personalized therapies that have a greater likelihood of getting FDA approval.  Undeniably, there is still risk involved that a drug will not make it to market, but the personalized medicine business is highly attractive solution for potential partners.  For a company such as Unilife, it can provide a valuable revenue stream as the drug company will be reliant on the device manufacturer for the supply of the device during the entire lifecycle of the drug including its original development.

Pfizer, Merck, Novartis, JNJ, GSK, BMS, sanofi-aveentis and Amgen are among the pharma companies developing new novel drugs such as injectable biologics that can be customized to meet the specifics needs of smaller sub-populations of patients.

Update on Monday, May 23, 2011 at 9:40AM by Michael W Sweeney

Unilife ($UNIS) - Taking Healthcare out of Hospitals and into the Home

Healthcare Megatrends:

• Healthcare costs continue to rise in 2011;
• Healthcare reform continues to remain a contentious issue in the U.S.;
• Hospital budgets continue to be squeezed as they are forced to do more with less;
• Patient self-administration of prescription medication is one of the fastest growing trends in the healthcare industry.

Nearly every industry gives consumers the power to make decisions. Whether it's choosing your own TV, your own house, car or job, consumers have some kind of major role in the decision. The medical industry has often been at odds with patient control, but that trend is changing.

One of the biggest advancements in the area of oral and injectable medications has been giving patients the ability to administer medication from the comfort of their own home. This means having the patients take a more active role in their healthcare, including the self-administration of medication. The squeeze on hospital budgets and rising healthcare costs lay the groundwork for pre-filled syringes as a way for the healthcare system to cut costs, improve efficiency and increase patient compliance. As such, physicians are more willing to write a prescription for a drug that a patient can easily administer themselves, despite the fact the drug may be more expensive. Now, with the help of Unilife Corp (NASDAQ: $UNIS; Stock Twits: $UNIS), the medical industry is beginning to revolutionize how drugs are delivered to patients.

Unilife is a U.S. based developer, manufacturer, and supplier of advanced drug delivery systems with state-of-the-art facilities located in Pennsylvania. Unilife works with pharmaceutical and biotechnology companies seeking innovative delivery devices. Unilife has developed a broad, differentiated, proprietary portfolio of injectable drug delivery products, including the Unifill^® and Unitract^® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. The patient benefits of pre-filled syringes include exact dosing and minimizing contamination risk.

Many drug companies are looking to the pre-filled syringe industry for help, as patients take a more active role in managing their disease or illness. The disease list includes:

• Multiple sclerosis;
• Arthritis;
• Osteoporosis;
• Anti-infectives;
• Immunostimulants used during chemotherapy.

Chairman Jim Bosnjak recently sent out this letter to shareholders, explaining that the company is positioned for strong growth:

"I am pleased to state that we have already identified strong interest from several leading pharmaceutical companies seeking to appoint a preferred partner to support them in the convergence of their novel patient-centric drugs with innovative, customized delivery devices. We thus expect to begin entering into agreements with pharmaceutical companies shortly not only for the Unifill syringe and other pipeline products, but additional new devices for complementary therapeutic areas that will greatly expand the size and scope of our industry presence.  Moving forward, Unilife is committed to be the preferred partner to pharmaceutical companies in the development, commercialization and supply of novel drug delivery devices across a significant number of therapeutic classes."

In addition to Unilife, Novo Nordisk, Lilly, Sanofi-Aventis, and Becton Dickinson also stand to benefit from this growing trend, and Unilife believes that it is particularly well positined in this market with sales to pharmaceutical companies beginning in the summer of 2011.

Update on Thursday, May 26, 2011 at 2:40PM by Michael W Sweeney

Unilife Corp ($UNIS) presented this week at UBS Specialty Pharma Conference in London. Ramin Mojdeh, Ph.D., who is Unilife’s Executive Vice President and Chief Operating Officer, conducted a presentation entitled “Innovative Drug Delivery Device Solutions” at the conference. Unilife is a manufacturer and supplier of advanced drug delivery systems to pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines.

Unilife will soon transition itself from a development company to a production company, as their Unifill product will begin shipping in July 2011. Unifill is the world’s first and only prefill syringe system with a fully integrated safety mechanism. It is a primary drug container, a safety device, and a sharps containment all in one. After a patient finishes the dose, the needle in Unifill retracts inside the glass barrel automatically and is fully contained and locked. The speed of retraction is controlled by the user’s thumb. Key points related to the Unifill syringe include:

• ·     
• ·     
• ·     
• ·     
• ·      The company c

Dr. Mojdeh’s presentation outlined how Unilife continues to focus on two areas:

• ·      Short term differentiation
• ·      Longer term innovation

Unilife is positioned as a technology leader with a customer-first orientation. Technology differentiation for customer’s include:

• ·     
• ·      Syringe systems with integrated safety and novel transfer mechanisms;
• ·      Dry drug reconstitution and delivery technologies;
• ·      Large-volume viscous drugs delivery;
• ·      Targeted organ delivery devices;
• ·      Multi-chamber proprietary primary containers and delivery systems;
• ·     

Mojdeh also outlined Unilife’s market opportunity in 2015, which is expected to be $30 billion in the injectable drug delivery device market with a growth rate of over 12% annually. This is:

• ·      Large macromolecule composition of pharmaceutical pipeline -
• ·      Patent Cliff - This is a major growth driver for the device market as 30 branded biologics will lose patent protection by 2015:
  • o   Brand companies want to differentiate their product to protect and grow their market share, and
  • o  
  • ·      Safety legislation and sharps management -
  • ·      Drug differentiation
  • ·      Aging population
  • ·      Developing Nations
  • ·      Self Administration

Update on Thursday, May 26, 2011 at 2:43PM by Michael W Sweeney

Unilife Corp ($UNIS) presented this week at UBS Specialty Pharma Conference in London. Ramin Mojdeh, Ph.D., who is Unilife’s Executive Vice President and Chief Operating Officer, conducted a presentation entitled “Innovative Drug Delivery Device Solutions” at the conference. Unilife is a manufacturer and supplier of advanced drug delivery systems to pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines.

Unilife will soon transition itself from a development company to a production company, as their Unifill product will begin shipping in July 2011. Unifill is the world’s first and only prefill syringe system with a fully integrated safety mechanism. It is a primary drug container, a safety device, and a sharps containment all in one. After a patient finishes the dose, the needle in Unifill retracts inside the glass barrel automatically and is fully contained and locked. The speed of retraction is controlled by the user’s thumb. Key points related to the Unifill syringe include:

• Unifill is a substitute for ALL standard prefill syringe systems – over 2.5 billion are used annually.
• Unifill can provide a powerful brand differentiation for the drugs it delivers.
• Unifill serves as the engine for next generation autoinjectors.  
• Sanofi invested $40 million in Unilife in part to develop and have reserve access to Unifill.  
• The company currently has capacity of 60 million units, and has a planned 150 million unit line extension.

Dr. Mojdeh’s presentation outlined how Unilife continues to focus on two areas:

• Short term differentiation – Unilife’s products are designed to be unique offerings, with integrated safety and other value-add features.
• Longer term innovation - Unilife partners with pharmaceutical companies to identify and address their emerging unmet needs in delivering specific molecules of therapeutic classes. Products are/will be designed to address the emerging needs of novel pipeline drugs.  

Unilife is positioned as a technology leader with a customer-first orientation. Technology differentiation for customer’s include:

• Integrated proprietary drug containers with value-add and customization features – This class was viewed by Mojdeh as a “game changer”. One of the key characteristics of this product class is that the drug container and fluid path remain the same across the entire family. Customers can start their drug stability studies in parallel with the development of their customized device.
• Syringe systems with integrated safety and novel transfer mechanisms;
• Dry drug reconstitution and delivery technologies;
• Large-volume viscous drugs delivery;
• Targeted organ delivery devices;
• Multi-chamber proprietary primary containers and delivery systems;
• Reusable and disposable self-administration device technologies – Many of Unilife’s technologies lend themselves to self-administration applications that address a growing market need.

Mojdeh also outlined Unilife’s market opportunity in 2015, which is expected to be $30 billion in the injectable drug delivery device market with a growth rate of over 12% annually. This is:

• Large macromolecule composition of pharmaceutical pipeline - The pharmaceutical drug pipeline has a significant number of large macromolecules targeting acute and chronic diseases.  These are biologic drugs that are almost entirely injectable, both in the form of liquid and powder to be reconstituted.
• Patent Cliff - This is a major growth driver for the device market as 30 branded biologics will lose patent protection by 2015:
• Brand companies want to differentiate their product to protect and grow their market share, and
• Generic companies want to differentiate their products to take a bigger market share from brand companies and other generic entrants.
• Safety legislation and sharps management - Needle stick injuries continue to be a major problem for healthcare and people who are at risk of needle stick injuries such as family members of patients and those who manage waste. 
• Drug differentiation – According to Mojdeh, a number of industry studies show that drug delivery devices have an increasing impact on the value of the drug-device combination. Devices are critical in patient acceptance, safety, ease of use, convenience, life style considerations, etc. 
• Aging population - The global population is aging and with that comes more diseases of aging, often chronic in nature, such as cancer, autoimmune diseases, obesity, etc.  These diseases often require periodic injections for a long time, perhaps the rest of one’s life.  This epidemiology trend bodes well for the growth potential in the device market.
• Developing Nations - The developing nations are transforming their medical practice as their economies strengthen, the demand for healthcare explodes, and they gain access to these advanced drugs. 
• Self Administration - There is a continuing shift from clinicians administering injectable drug to self administration in home care settings.  This is largely driven by many factors including healthcare economics, therapy compliance, and patient empowerment.