Company and People Notes: Novartis to Acquire Nektar Drug Delivery Unit; LifeCycle Pharma Appoints Jim New As President and CEO; More...

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, MedImmune opens Cambridge, UK, facility and makes reverse engineering pact with Omninvest; BD Medicine appoints Carol Adiletto VP of clinical and regulatory affairs; more...

Company Notes

St. Paul, MN (Oct. 20)-3M Drug Delivery Systems entered into an agreement with VaxInnate (Cranbury, NJ) to develop a flu vaccine patch for use against a pandemic flu outbreak. The nonexclusive license agreement provides VaxInnate with use of patented 3M microneedle technology, called "3M Microstructured Transdermal System" technology, to deliver its "M2e" universal flu vaccine using a transdermal patch instead of a traditional injection.

Lake Forest, IL (Oct. 13)-Akorn, a specialty pharmaceutical company, entered into a five year-supply agreement for an ophthalmic product with an undisclosed ophthalmic company. Akorn is the abbreviated new drug application holder of the product. Under the terms of the five-year agreement, Akorn will be responsible for the manufacturing and supply of the ophthalmic product. Revenues from this agreement are expected to begin in early 2009.

Hunenberg, Zug, Switzerland (Oct. 14)-The eye-care company Alcon entered into a licensing agreement with GlaxoSmithKline (London) for global ophthalmic rights to cilomilast, a phosphodiesterase IV inhibitor. In addition to this new agreement, Alcon expanded its existing drug research alliance with Origenis (Martinsried, Bavaria, Germany) with a focus on the discovery and development of the small molecules that might one day have a role in the treatment of eye diseases.

Hayward, CA (Oct. 8)-Aradigm, a specialty pharmaceutical company, received a portfolio of inhaled-insulin-related patents that was transferred by Novo Nordisk (Bagsværd, Hovedstaden, Denmark). The transfer was pursuant to a license agreement between Aradigm and Novo Nordisk that was terminated in May 2008. Novo Nordisk purchased a significant portion of the portfolio from Aradigm in July 2006 and supplemented the portfolio with certain of its own related patents. The portfolio includes both US and foreign patents. Aradigm assumes responsibility for the maintenance of this portfolio.

Hollywood, FL (Oct. 20)-Azopharma Product Development Group entered the microdosing market. The company now offers services to synthesize material amenable to microdose studies as well as formulate, administer microdoses in a clinical environment, and analyze samples.

Somerset, NJ (Oct. 14)-Catalent Pharma Solutions, a provider of outsourced clinical and commercial packaging services, opened a new temperature-controlled warehouse in Bolton, Greater Manchester, England, to meet demand for clinical supply services, especially cold-chain storage and distribution. The 11,800-ft2 warehouse is an extension of the existing facility and features 2000 controlled ambient storage locations and a 320-pallet refrigerator. 

The company also announced last week that the US Food and Drug Association has approved the sale of a prescription product manufactured in Catalent’s recently opened prefilled syringe facility in Brussels, Belgium. Syringes from the Brussels facility will likely be dispensed to patients in the US in coming months.

Wilmington, MA (Oct. 15)-Charles River Laboratories, a contract research organization, opened 60,000-ft2 preclinical facility in Shanghai. The new China facility will help Charles River support clients’ global drug development needs. The new facility is expected to provide good laboratory practice (GLP) services in the first quarter of 2009.

London (Oct. 15)-GlaxoSmithKline (GSK) will acquire the Egyptian mature products business of Bristol-Myers Squibb (New York), for $210 million, in a move to accelerate sales growth and extend its pharmaceutical portfolio in emerging markets. As a result of the acquisition, GSK will become the leading pharmaceutical company in Egypt with a market share of approximately 9%.

Bristol, TN (Oct. 13)-King Pharmaceuticals extended its previously announced tender offer for all outstanding shares of Class A Common Stock of Alpharma until Nov. 21, 2008, unless the offer is further extended. The Sept. 12, 2008, offer was originally scheduled to expire Oct. 10, 2008. All other terms and conditions of the tender offer remain unchanged. As of the close of business on Oct. 10, approximately 18.8 million shares of Class A Common Stock of Alpharma (including approximately 3.4 million shares subject to guarantees of delivery), representing approximately 45% of all outstanding shares, were validly tendered and not withdrawn pursuant to the tender offer. On Sept. 26, Alpharma’s board issued a statement rejecting King’s tender offer, calling it “financially inadequate.”

Gaithersburg, MD (Oct. 16)-The biotechnology company MedImmune licensed its proprietary reverse genetics intellectual property to Omninvest (Budapest, Hungary), a research and manufacturing company, to support the development and construction of new vaccine strains to produce non-live human influenza vaccines. For potential pandemic influenza vaccines, reverse genetics can be a useful technology because the process does not require manufacturers to work directly with potentially highly infectious pandemic strains, such as H5N1, rather only with segments of the virus's genome.

MedImmune also announced last week the opening of a new 92,000-ft2 biologics research and development (R&D) facility in Cambridge, Cambridgeshire, England. Named after the 1982 Nobel Prize winner for chemistry, the Aaron Klug Building is a major expansion of MedImmune's existing Granta Park site.

Basel (Oct. 21)-Novartis will acquire the pulmonary drug-delivery business unit of Nektar Therapeutics for $115 million in cash. Novartis will gain Nektar’s capabilities in product formulation, its delivery expertise, and a broad device platform. This transaction excludes Nektar's inhalation programs for insulin, vancomycin, ciprofloxacin and amikacin. Approximately 140 Nektar associates will join Novartis and remain in San Carlos, California.

Woodcliff Lake, NJ (Oct. 14)-Par Pharmaceutical Companies will resize its generic unit, trimming its generic product portfolio and retaining those considered the most profitable for the company. This will result in a workforce reduction of approximately 190 employees.  Approximately 30% of the affected positions in manufacturing, R&D, and general and administrative will be eliminated by year-end 2008 and the remaining positions by the end of first half of 2009. 

Goettingen, Lower Saxony, Germany (Oct. 20)-Sartorius Stedim Biotech GmbH and Bayer Technology Services GmbH (Leverkusen, North Rhine-Westphalia, Germany), signed an exclusive cooperation agreement to manufacture and market “UVivatec” products. With the technology developed by Bayer, viruses are inactivated in biopharmaceuticals by UVC irradiation. Typical areas of use are virus inactivation of cell culture media, antibody solutions, and solutions containing recombinant proteins as well as irradiation of vaccines and therapeutics produced from blood and plasma.  Further areas of application, such as removal of mycoplasma from bioreactor media, are currently being assessed. The technology is scalable and marketed by Sartorius as single-use modules, laboratory bench units, and process systems.

Dekalb, IL (Oct. 6)-The packaging company Tegrant will create a joint venture with FEC (Hong Kong) an investment company focused on the Asian packaging market. The joint venture, ThermoSafe Brands Asia, will manufacture and distribute a full line of products in the region, including ThermoSafe insulated shippers, Polar Pack gels, U-tek phase change materials and Nomadic prequalified shipping solutions. ThermoSafe Brands Asia will be headquartered in Singapore.

People Notes

San Diego (Oct. 21)-Althea Technologies, a development- and manufacturing-services provider, named Shabbir Anik, PhD, president and chief executive officer. Anik will lead Althea's expansion of its product-development, clinical-trial, and commercial-manufacturing services. Anik is the former president of pharmaceutical development services at Patheon.

Waltham, MA (Oct. 20)-BG Medicine, a molecular-diagnostics firm, named Carol Adiletto vice-president of clinical and regulatory affairs. Adiletto will manage the company’s clinical and regulatory activities, as well as develop its regulatory strategy.

Horsholm, Denmark (Oct. 21)-LifeCycle Pharma, a specialty pharmaceutical company focusing on immunosuppression, appointed Jim New president and CEO. Hans Christian Teisen resigned as the executive vice-president and chief financial officer of LifeCycle to take a position as partner and CFO of PricewaterhouseCoopers, effective Dec. 1, 2008. Teisen will assist LifeCycle during the transition to the new CEO and CFO.

Basel (Oct. 20)-Novartis announced personnel changes that will become effective Dec. 1, 2008: Joerg Reinhardt, PhD, was appointed chief operating officer; Andrin Oswald will replace Joerg Reinhardt as head of vaccines and diagnostics; Andreas Rummelt, PhD, will assume the newly created position of group head of quality assurance and technical operations; Jeff George, currently head of emerging markets in the pharmaceuticals division, will replace Rummelt as the new head of Sandoz; and George Gunn was appointed head of consumer health in addition to his current role as head of the animal-health business unit. Gunn will replace Thomas Ebeling, who has decided to pursue his career outside the company. Click here to see more appointments in the full press release.

Cambridge, MA (Oct. 21)-Pervasis Therapeutics, a biotechnology company, named Frederic Chereau president and CEO. Chereau was formerly the vice-president and general manager of Genzyme Cardiovascular, a business unit within Genzyme Corporation in Cambridge.

Cambridge, MA (Oct. 20)-T2 Biosystems, a privately held biotechnology company developing next-generation medical diagnostic products, appointed Pamela J. Weagraff to the newly created position of vice-president of regulatory and quality. T2 Biosystems’s proprietary technology combines nanotechnology and miniaturized magnetic-resonance technology to provide rapid, portable diagnostics.