Clinical-stage collaboration

THOUSAND OAKS, Calif.—A clinical-stage inflammationportfolio from Amgen got a leg up in April when MedImmune, the biologics arm ofLondon-based pharma AstraZeneca PLC, signed an agreement to jointly develop andcommercialize five monoclonal antibodies that have the potential to delivernovel treatments across multiple indications in inflammatory diseases.

The agreement between AstraZeneca and Amgen calls forAstraZeneca to make a one-time, $50-million upfront payment and fundapproximately 65 percent of costs through 2014, after which the companies willsplit costs equally.

According to Dr. Bahija Jallal, executive vice president ofR&D at MedImmune, the collaboration will provide Amgen with additionalresources to optimally progress its portfolio and capitalize on AstraZeneca'sglobal commercial reach in respiratory and gastrointestinal diseases.

"We are looking all the time for new, innovative science, nomatter where it is," says Jallal. "We're particularly interested in early-stageassets in areas of unmet medical needs, with solid science to support them.What we saw in the portfolio and the collaboration is that they very much bringtogether complementary strengths in both organizations. We were attracted byAmgen's portfolio assets, which we didn't have yet, but because we have severalassets in our portfolio in respiratory diseases and asthma, adding ourcommercial strength brings a lot to Amgen as well. For me, this is a win-winsituation between our two organizations."

"By sharing development and commercialization costs with aknowledgeable partner in AstraZeneca/MedImmune, we have more flexibility tomaximize productivity, expand our capabilities to innovate internally andexternally and deliver the best pipeline for patients," adds Christine Regan, aspokeswoman for Amgen. "This collaboration provides Amgen with additionalresources to develop its leading inflammation portfolio and allows AstraZenecato deploy its expertise in inflammation and global commercializationcapabilities with a new portfolio of early development and late-stagecompounds."

The portfolio includes five clinical-stage monoclonalantibodies: AMG 139, which is being investigated in Phase Ib for Crohn'sdisease; AMG 181, which is being investigated in Phase Ia and Phase Ib forulcerative colitis and Crohn's disease; AMG 557, which binds to B7-relatedprotein 1 (B7RP-1) and is being investigated in Phase Ib for autoimmunediseases such as systemic lupus erythematosus; AMG 157, which blocksinteraction of thymic stromal lymphopoietin (TSLP) with the TSLP receptor andis being investigated in Phase Ib for asthma; and finally, Brodalumab (AMG827), which binds to and blocks signaling via the IL-17 receptor that is beinginvestigated for psoriasis (completed Phase I and planned Phase III), psoriaticarthritis (Phase II) and asthma (Phase II).

In particular, AstraZeneca was attracted to Brodalumab, asit has the potential to treat up to 25 million people worldwide who suffer frompsoriasis, says Jallal.

"Psoriasis is a very painful and unpleasant disease, andthere is still an unmet medical need in this growing market, especially in thebiologics space," Jallal notes. "If you look at the psoriasis biologics market,it is expected to grow by 32 percent in the next decade."

AstraZeneca will lead the development and commercialstrategy of AMG 139, AMG 157 and AMG 181, while Amgen will lead the developmentand commercial strategy of Brodalumab and AMG 557. Each development andcommercialization lead will be under the oversight of joint governing bodies.

The companies will also share profits, with Amgen retaininga "low, single-digit royalty" for Brodalumab and a "mid-single-digit royalty"for the rest of the portfolio, after which the companies will share profitsequally. The agreement does not include certain territories previouslypartnered by Amgen for Brodalumab with Kyowa Hakko Kirin and AMG 557 withTakeda.

In addition, commercial promotion for Brodalumab will besplit, with Amgen promoting the program in dermatology indications in theUnited States and Canada, and in rheumatology indications in the United States,Canada and Europe. AstraZeneca will promote the program in respiratory diseasesand dermatology indications across all territories outside of the UnitedStates, Canada and any markets where Amgen has existing partnerships. Thecompanies will decide at a later date about allocation of promotional rightsfor other territories, indications and molecules.

MedImmune's biologics pipeline represents 40 percent ofAstraZeneca's overall portfolio, so ultimately, bringing Amgen's programs tomarket "gives us the opportunity to be able to offer different options topatients, which is what really excites me," says Jallal.

"Amgen's assets in this area will complement our anti-inflammatoryportfolio and make it one of the strongest in the industry," she concludes.

Amgen acquires KAI Pharmaceuticals for $315 million

THOUSAND OAKS, Calif.—Amgen also announced last month anagreement under which Amgen will acquire KAI Pharmaceuticals, a privately heldpharmaceutical company based in South San Francisco, for $315 million in cash.

KAI's lead product candidate, KAI-4169, is a novel agentbeing initially studied for the treatment of secondary hyperparathyroidism(SHPT) in patients with chronic kidney disease (CKD) who are on dialysis. SHPT,a component of CKD mineral and bone disorder (MBD), is a common and seriouscomplication for patients with CKD who are on dialysis. Through thisacquisition, Amgen will acquire worldwide rights, excluding Japan, to KAI-4169.

KAI-4169 is an innovative experimental therapy that isadministered intravenously at the same time the patient is undergoing dialysis.The vast majority of CKD patients on dialysis are affected by SHPT, a componentof CKD-MBD, which can lead to serious consequences.

Under terms of the agreement, Amgen has also provided a loanto enable Phase III clinical development planning for KAI-4169 prior to theclosing of the transaction, which has been approved by the board of directorsof both companies. Once customary closing conditions have been met, KAI willbecome a wholly owned subsidiary of Amgen.

"KAI has demonstrated encouraging results in the clinic. Weare excited about acquiring KAI, as well as the opportunity to potentiallydeliver a novel therapy for chronic kidney disease patients on dialysissuffering from secondary hyperparathyroidism," said Dr. Sean E. Harper,executive vice president of research and development at Amgen, in a statement.

"KAI and the nephrology community are excited by the additional clinicaldata we've generated for KAI-4169, and we are thrilled that Amgen shares our perspectiveon the differentiated profile and potential of this product candidate," addedSteve James, president and CEO of KAI. "Amgen is ideally positioned to bringKAI-4169 to market and to patients, given the company's decades of experiencein developing and delivering therapies for patients with chronic kidneydisease."