Laureate Pharma has entered into a cGMP contract manufacturing agreement with Cytheris SA, a clinical stage biopharma focused on immune modulation. Laureate will manufacture Cytheris' lead product candidate, Interleukin-7 (IL-7), a fully glycosylated recombinant human protein and critical growth factor for immune T-cell recovery, for use in ongoing international clinical trials currently being conducted for treatment of HIV, HCV and cancer. Terms and conditions of the agreement were not disclosed.

"We are delighted that Cytheris has selected us again as their CMO, to manufacture IL-7 in support of their expanded clinical trial program. This is a testimonial to our successful partnership with our clients and our effort to achieve their total satisfaction in our ability to meet their manufacturing needs," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. "We will work with the Cytheris team very closely and help them realize the greatest potential of their IL-7 development and production program."

"As we move towards large scale production of our IL-7 biotherapeutic, we are pleased to continue our strong working relationship with Laureate Pharma," said Michel Morre, DVM, president and chief executive officer of Cytheris. "With Laureate's demonstrated skill in successful transfer of process technology, we look forward to continuing to work together in the process scale-up, engineering and clinical material production of IL-7 for our ongoing clinical trials investigating multiple indications."

Shire and TAP Pharmaceutical Products Inc. have inked a three-year, U.S. co-promotion pact for Shire's Lialda with MMX technology, which is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC). The agreement will add more than 500 sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing Lialda primarily to gastroenterologists.

"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the U.S.," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."

Lialda is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well- established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.

"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."

The TAP sales force will begin detailing LIALDA to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.

Quintiles Transnational has signed an agreement with Medca Japan to provide central laboratory services in Japan. Quintiles will have its own staff at the College of American Pathologoists-certified Medca laboratory in Saitama, a city in the Greater Tokyo area. The lab will support clinical trials in Japan.

"Recent changes in legislation are allowing Japanese pharmaceutical companies to extend clinical trials normally conducted in Japan to other countries in Asia, but these companies have had difficulty finding central lab services that are harmonized throughout the region," said Tom Wollman, senior vice president, Quintiles Global Central Laboratories. "With CAP-certified labs in Beijing, Singapore, Mumbai and now Japan, we can provide well-controlled processes and harmonized testing services throughout the Asia-Pacific region to customers in Japan as well as our multinational customers. This lab, along with all labs in our network, will follow the same standard operating procedures, and data will be available on our QNET database."

"This collaboration with Quintiles will be very helpful for the future success of Medca Japan," said Yutaka Kannari, president of Medca Japan Laboratory Co., Ltd. "We receive more than 30,000 specimens for examination per day, and this relationship will allow us to strengthen out clinical trial services while supporting continued growth of our existing laboratory operations."

Medca provides a broad range of laboratory services, including biochemical tests as well as endocrine testing, tumor marker testing, drug-level testing, immunology testing and microbiological testing. The laboratory has undertaken specimens for examination from about 4,000 medical institutions throughout Japan.

The relationship with Medca will be managed within Quintiles by Alan Ong, Vice President and General Manager, Quintiles Labs Asia, who will give technical guidance, and Narimatsu, who will provide his expertise on the Japan market.

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