Thousand Oaks, CA, and Ingelheim, Germany (Press Release) – Amgen (NASDAQ: AMGN) and Boehringer Ingelheim today announced that Amgen has acquired global devel­op­ment and commercial rights from Boehringer Ingelheim for BI 836908 (AMG 420), a bispecific T cell engager (BiTE®) that targets B-cell maturation an­ti­gen (BCMA), a poten­tial target for multiple myeloma. BI 836908 (AMG 420) is cur­rently in Phase 1 studies. BI 836908 (AMG 420) was originally licensed to Boehringer Ingelheim by Micromet before the com­pany was acquired by Amgen in 2012.

Under the provisions of the agree­ment, Amgen will work with Boehringer Ingelheim to assume re­spon­si­bil­ity­ for the clin­i­cal devel­op­ment of BI 836908 (AMG 420), transfer manu­fac­tur­ing, and lead global regu­la­tory activity moving forward. Amgen will also receive world­wide com­mer­cial­iza­tion rights for BI 836908 (AMG 420). Prior to this agree­ment, Boehringer Ingelheim held global devel­op­ment and com­mer­cial­iza­tion rights. Financial terms of the agree­ment are not being disclosed.

"Obtaining global rights to BI 836908 (AMG 420) ad­vances Amgen's immuno-oncology strategy, allow­ing us to leverage our expertise with the BiTE® plat­form to target BCMA in the multiple myeloma setting," said Sean E. Harper, M.D., exec­u­tive vice pres­i­dent of Research and Development at Amgen. "Multiple myeloma is a rare and aggressive blood cancer and despite new ad­vances there is cur­rently no cure.^1-3 BI 836908 (AMG 420) allows us to explore a poten­tial new treat­ment ap­proach that harnesses the immune system to fight multiple myeloma."

"Boehringer Ingelheim is delighted that Amgen will con­tinue our suc­cess­ful devel­op­ment of this im­por­tant com­pound for multiple myeloma," said Dr. Jörg Barth, corporate senior vice pres­i­dent, Therapy Area Head Oncology at Boehringer Ingelheim. "Given Amgen's focus in this disease area, we are convinced this best sup­ports the future devel­op­ment for BI 836908 (AMG 420) and the goal to ultimately offer new treat­ment options for patients. Immuno-oncology and T cell engagers remain a key area of focus for Boehringer Ingelheim as well as providing inno­va­tive treat­ments for lung and blood cancers."

About BI 836908 (AMG 420)

BI 836908 (AMG 420) is a bispecific T cell engager (BiTE®) that is under in­ves­ti­ga­tion for the treat­ment of multiple myeloma. BI 836908 (AMG 420) targets B-cell maturation an­ti­gen (BCMA), a target in multiple myeloma due to its restricted normal tissue ex­pres­sion and uniform ex­pres­sion on multiple myeloma cells. BI 836908 (AMG 420) is cur­rently being eval­u­ated in Phase 1 studies.

About BiTE® Technology

Bispecific T cell engager (BiTE®) anti­body con­structs are a type of immuno­therapy being in­ves­ti­gated for fighting cancer by helping the body's immune system to detect and target malignant cells. The modified anti­bodies are designed to engage two dif­fer­en­t targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® anti­body con­structs help place the T cells within reach of the targeted cell, with the intent of allow­ing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® anti­body con­structs are cur­rently being in­ves­ti­gated for their poten­tial to treat a wide variety of cancers. For more in­for­ma­tion, visit www.biteantibodies.com.

About Amgen

Amgen is committed to unlocking the poten­tial of biology for patients suffering from serious illnesses by discovering, devel­op­ing, manu­fac­tur­ing and delivering inno­va­tive human thera­peutics. This ap­proach begins by using tools like ad­vanced human genetics to unravel the complexities of disease and under­stand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solu­tions that im­prove health out­comes and dramatically im­prove people's lives. A bio­technology pioneer since 1980, Amgen has grown to be one of the world's leading independent bio­technology com­pa­nies, has reached millions of patients around the world and is devel­op­ing a pipe­line of medicines with break­away poten­tial.

For more in­for­ma­tion, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Boehringer Ingelheim in Oncology

Oncology is one of five key focus areas for Boehringer Ingelheim with 13 com­pounds in clin­i­cal devel­op­ment across a broad range of solid tumors and blood cancers. This in­cludes non-small cell lung cancer, squamous cell carcinoma of the lung, acute myeloid leukemia, chronic lym­pho­cytic leukemia and myelo­dys­plastic syn­dromes. In addi­tion, BI con­tinues with key strategic part­ner­ships in on­col­ogy all with a focus on im­prov­ing the lives of patients with cancer.

Boehringer Ingelheim is one of the world's 20 leading pharma­ceu­tical com­pa­nies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned com­pany, founded in 1885, is on researching, devel­op­ing, manu­fac­tur­ing and market­ing new medications of high thera­peutic value for human and veterinary medicine.

Social re­spon­si­bil­ity­ is an im­por­tant element of the corporate cul­ture at Boehringer Ingelheim. This in­cludes world­wide involvement in social projects through, for example, the ini­tia­tive "Making More Health" while also caring for employees. Respect, equal oppor­tu­ni­ty and reconciling career and family form the foundation of mutual cooperation. The com­pany also focuses on en­viron­mental protection and sustainability in everything it does.

For more in­for­ma­tion please visit www.boehringer-ingelheim.com.

Amgen Forward Looking Statements

This news release con­tains forward-looking state­ments that are based on the current ex­pec­ta­tions and beliefs of Amgen. All state­ments, other than state­ments of historical fact, are state­ments that could be deemed forward-looking state­ments, in­­clud­ing esti­mates of revenues, operating margins, capital ex­pen­di­tures, cash, other financial metrics, ex­pec­ted legal, arbitration, political, regu­la­tory or clin­i­cal results or practices, customer and prescriber patterns or practices, reim­burse­ment activities and out­comes and other such esti­mates and results. Forward-looking state­ments involve sig­nif­i­cant risks and un­cer­tain­ties, in­­clud­ing those discussed below and more fully described in the Securities and Exchange Com­mis­sion reports filed by Amgen, in­­clud­ing its most recent annual report on Form 10-K and any sub­se­quent periodic reports on Form 10-Q and Form 8-K. Unless other­wise noted, Amgen is providing this in­for­ma­tion as of the date of this news release and does not under­take any obli­ga­tion to update any forward-looking state­ments con­tained in this document as a result of new in­for­ma­tion, future events or other­wise.

No forward-looking state­ment can be guar­an­teed and actual results may differ ma­teri­ally from those Amgen projects. Discovery or identi­fi­ca­tion of new prod­uct can­di­dates or devel­op­ment of new indi­ca­tions for existing prod­ucts cannot be guar­an­teed and movement from concept to prod­uct is uncertain; consequently, there can be no guar­an­tee that any particular prod­uct can­di­date or devel­op­ment of a new indi­ca­tion for an existing prod­uct will be suc­cess­ful and become a commercial prod­uct. Further, pre­clin­i­cal results do not guar­an­tee safe and effective per­for­mance of prod­uct can­di­dates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell cul­ture systems or animal models. The length of time that it takes for Amgen to com­plete clin­i­cal trials and obtain regu­la­tory approval for prod­uct market­ing has in the past varied and Amgen ex­pec­ts similar variability in the future. Even when clin­i­cal trials are suc­cess­ful, regu­la­tory author­i­ties may question the sufficiency for approval of the trial end­points Amgen has selected. Amgen develops prod­uct can­di­dates internally and through licensing col­lab­o­rations, part­ner­ships and joint ventures. Product can­di­dates that are derived from rela­tion­ships may be subject to disputes be­tween the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such rela­tion­ship. Also, Amgen or others could identify safety, side effects or manu­fac­tur­ing problems with its prod­ucts after they are on the market.

Amgen's results may be affected by its ability to suc­cess­fully market both new and existing prod­ucts domestically and inter­na­tionally, clin­i­cal and regu­la­tory devel­op­ments involving current and future prod­ucts, sales growth of recently launched prod­ucts, com­pe­ti­tion from other prod­ucts in­­clud­ing bio­sim­i­lars, dif­fi­culties or delays in manu­fac­tur­ing its prod­ucts and global economic con­di­tions. In addi­tion, sales of Amgen's prod­ucts are affected by pricing pressure, political and public scrutiny and reim­burse­ment policies imposed by third-party payers, in­­clud­ing gov­ern­ments, private insurance plans and man­aged care providers and may be affected by regu­la­tory, clin­i­cal and guideline devel­op­ments and domestic and inter­na­tional trends to­ward man­aged care and health­care cost con­tainment. Further­more, Amgen's research, testing, pricing, market­ing and other operations are subject to extensive reg­u­la­tion by domestic and foreign gov­ern­ment regu­la­tory author­i­ties. Amgen or others could identify safety, side effects or manu­fac­tur­ing problems with its prod­ucts after they are on the market. Amgen's business may be impacted by gov­ern­ment in­ves­ti­ga­tions, litigation and prod­uct liability claims. In addi­tion, Amgen's business may be impacted by the adoption of new tax legislation or exposure to addi­tional tax liabilities. If Amgen fails to meet the compliance obli­ga­tions in the corporate integrity agree­ment be­tween it and the U.S. gov­ern­ment, Amgen could become subject to sig­nif­i­cant sanctions. Further, while Amgen routinely obtains patents for its prod­ucts and tech­nology, the protection offered by its patents and patent appli­ca­tions may be chal­lenged, invalidated or circumvented by its com­pet­i­tors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen per­forms a sub­stan­tial amount of its commercial manu­fac­tur­ing activities at a few key manu­fac­tur­ing facilities and also depends on third parties for a portion of its manu­fac­tur­ing activities, and limits on supply may constrain sales of certain of its current prod­ucts and prod­uct can­di­date devel­op­ment. In addi­tion, Amgen competes with other com­pa­nies with respect to many of its marketed prod­ucts as well as for the discovery and devel­op­ment of new prod­ucts. Further, some raw ma­teri­als, medical devices and component parts for Amgen's prod­ucts are supplied by sole third-party suppliers. The discovery of sig­nif­i­cant problems with a prod­uct similar to one of Amgen's prod­ucts that implicate an entire class of prod­ucts could have a ma­teri­al adverse effect on sales of the affected prod­ucts and on its business and results of operations. Amgen's efforts to acquire other com­pa­nies or prod­ucts and to integrate the operations of com­pa­nies Amgen has acquired may not be suc­cess­ful. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Amgen is in­creas­ingly dependent on in­for­ma­tion tech­nology systems, infrastructure and data security. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business per­for­mance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock.

The scientific in­for­ma­tion discussed in this news release related to Amgen's prod­uct can­di­dates is pre­lim­i­nary and investigative. Such prod­uct can­di­dates are not approved by the U.S. Food and Drug Admin­istra­tion, and no conclusions can or should be drawn re­gard­ing the safety or effectiveness of the prod­uct can­di­dates.

References

1. National Cancer Institute. 2015. SEER Stat Fact Sheets: Myeloma. Available at: http://seer.cancer.gov/statfacts/html/mulmy.html.
2. American Cancer Society website. Multiple myeloma. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf. Accessed February 1, 2016.
3. Jakubowiak A. Management Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives

Source: Amgen.