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They’re bonded by blood
August 2009
by Lori Lesko  |  Email the author
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SOUTH SAN FRANCISCO, Calif.—Biotech innovator Catalyst Biosciences Inc. has granted Wyeth Pharmaceuticals exclusive worldwide rights to develop and commercialize CB 813, a recombinant human coagulation Factor VIIa, to treat and prevent acute bleeding in hemophilia patients. The companies also teamed up for a two-year research agreement to discover and develop additional Factor VIIa compounds.

The collaboration, announced June 30, includes an upfront payment of $21 million, with the potential to bring South San Francisco's Catalyst up to $40 million over the next two years. The ultimate value of the deal, not counting any eventual royalties, could amount to $500 million in research funding and milestone payments.

Based in Collegeville, Pa., Wyeth, one of the world's largest research-driven pharmaceutical companies, has the option to extend the two-year research portion of the collaboration for up to three additional years. During the research term of the agreement, Catalyst will receive support for up to 12 full-time employees.

The deal stipulates that Wyeth will be responsible for the development, manufacturing and worldwide commercialization of products resulting from the collaboration. In addition, during the research term, Wyeth would have the right of first negotiation to two other Catalyst programs—one on Factor IX—which is in discovery, and another on an undisclosed clotting factor discovered by Catalyst to treat hemophilia and other bleeding conditions. Catalyst's role in the collaboration is to discover the compounds and conduct pre-clinical development.

The lucrative venture is not expected to be compromised or altered by Pfizer's $68 billion merger with Wyeth in January. Catalyst Biosciences CEO Nassim Usman remains confident that the terms of the Wyeth partnership will stand.

"We feel pretty strongly that there will be good continuity going forward following the Pfizer acquisition of Wyeth," Usman says.

Pfizer's commitment to furthering its biotech aspects were made clear in April, when it named Wyeth's R&D chief, Mikael Dolsten, as head of the proposed merger's biotherapeutic's research group, Usman says. Dolsten has referred to the collaboration with Catalyst as an "excellent fit," which provides the opportunity to expand Wyeth's hemophilia franchise.

Usman stated in a company press release that Catalyst is "thrilled to join forces with Wyeth, a biopharmaceutical company at the forefront of both hemophilia treatment and the development and commercialization of biologic therapies. This collaboration highlights the value Catalyst has created in our Factor VIIa portfolio of products.  Revenues generated from research collaborations such as this one allow us to continually expand and support existing discovery efforts around bleeding disorder product candidates and the engineering of new Alterase therapeutic products."

In April, Wyeth reported that its three hemophilia products on the market, Xyntha, ReFacto and BeneFIX, produced $206 million in worldwide sales revenue during the first quarter of 2009, down 14 percent from one year prior.

Wyeth's expertise made for the ideal partner in this venture, as well as Wyeth's longstanding commitment to developing biologics, Usman says. Wyeth's financial terms may have made the deal too good to refuse.

This is actually the second collaboration between the two companies. Catalyst and Wyeth first partnered up in January 2007 to discover and investigate potential therapies for oncology and metabolic disease.

Bob Repella, executive vice president and general manager of Wyeth's biopharma business unit, says Wyeth was attracted to the collaboration "because of its advanced technology in protein engineering, and their work on CB 813, one of Catalyst's Factor VIIa variants. Wyeth brings an established franchise for hemophilia A and hemophilia B, and has extensive expertise and resources in biological manufacturing, hemophilia clinical programs, regulatory expertise and commercialization of hemophilia products and biologics in general."

In addition to CB 813, "Catalyst brings technology and know-how for identifying, modifying and characterizing proteases, including catalytic activity, altered specificity, resistance to inhibitors, enhanced or reduced co-factor dependence and increased pharmacokinetic or pharmacodynamic activity," Repella says.

"About one in 5,000 males is born with hemophilia A, and about one in 30,000 males is born with hemophilia B," Repella notes. "According to the World Federation of Hemophilia (WFH), an estimated 400,000 people worldwide are living with hemophilia. Only 25 percent receive adequate treatment. The WFH is striving to close this gap. In the United States, the CDC estimates that 18,000 individuals—primarily males—live with hemophilia."

The Catalyst/Wyeth collaboration has the potential to develop therapies to not only effectively treat hemophilia patients, but other bleeding conditions, as well, Repella says. This includes people who suffer profuse bleeding as a result of surgery or trauma.

Catalyst Biosciences inks $195 million research pact with MedImmune

SAN FRANCISCO, Calif.—One week after heralding a new partnership with Wyeth Pharmaceuticals, Catalyst Biosciences has unveiled a research and licensing agreement with MedImmune worth up to $195 million in upfront fees, employee support and milestones. MedImmune, the global biologics unit of AstraZeneca PLC, has agreed to develop drug candidates against two targets, one of which will address inflammatory and autoimmune diseases.

Under the terms of the partnership, announced July 7, MedImmune will support the discovery research and preclinical development of Alterase therapeutics against an undisclosed target, with an option to expand the agreement to include a second target.

MedImmune, headquartered in Gaithersburg, Md., will be responsible for all development, manufacturing and commercialization efforts for any products it discovers.

Alterases are next-generation proteases engineered by Catalyst to cleave to and inactivate disease-causing proteins. While existing proteases—Botox, Xigris and blood products Factor VII and Factor IX—act against a single target, the disease target for Alterases can be changed to potentially act against a range of diseases, explained Catalyst Biosciences CEO Nassim Usman. Catalyst can take those proteases and make them work more effectively so the targets can be changed and new diseases could be targeted with Alterases.

"We are very pleased to add MedImmune, a leading developer of biologic therapies, as a partner,"  Usman said in a company press release. "Our Alterase drug discovery engine is creating novel next-generation protein therapeutics against a broad variety of important disease targets. Collaborations such as this demonstrate the high value of our discovery and protein-engineering capabilities."

Furthermore, the collaboration with Wyeth for the treatment of hemophilia, announced June 30, and the MedImmune partnership, announced one week later, along with a $40 million round of venture financing last year, gives Catalyst enough cash through 2013, Usman said. Both deals provided new upfront capital to Catalyst, with Wyeth paying $21 million in cash upfront, and MedImmune to pay an undisclosed upfront cash payment.

Catalyst's latest collaborations are part of a larger partnering strategy that includes a partnership with Wyeth's pharmaceutical division, formed in 2007, for its Alterase therapeutics platform. In addition, Catalyst partnered with Centocor Research & Development Inc. in 2008 for the development of two Alterase drug candidates.

These lucrative deals, all flush with cash, means Catalyst, a private company with 50 employees, may not have to raise venture capital funding again in the future.

"We have no plans to take additional venture funding," Usman said. "At the moment, we're going to focus on the existing collaborations and our internal programs, too, of course. While the deals are enormous for us, they are in the early stages of development and we can't say at this point, the impact these collaborations will have on Big Pharma."
 
 
Code: E080922

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