Takeda related Press Releases

Takeda Announces Establishment of Development Center in China

Jennifer Levin — Thu, 09 Feb 2012 09:42:50 -0500

Takeda Announces Establishment of Development Center in China

February 9, 2012
Takeda Pharmaceutical Company Limited Takeda Announces Establishment of Development Center in China

Osaka, Japan, February 09, 2012-Takeda Pharmaceutical Company Limited ("Takeda") announced today the establishment of the Takeda Shanghai Development Center ("TSDC") within the Shanghai-based Takeda (China) Holdings Co., Ltd. ("TCH"), which is a wholly owned subsidiary of Takeda.

This important step reflects Takeda's strategic commitment to Asia and to China in particular. Takeda is now enhancing its business in China through TCH's wholly owned subsidiaries, Takeda Pharmaceutical (China) Company Limited in Taizhou ("Takeda China"), which is responsible for manufacturing, and Tianjin Takeda Pharmaceuticals Co., Ltd, in Tianjin ("Tianjin Takeda"), which is responsible for marketing and sales. Together with Takeda China and Tianjin Takeda, TSDC will help to drive Takeda's ambitious growth agenda in China and in the broader Asian region.

Within Asia outside Japan, including China, drug development is overseen by Takeda Global Research & Development Center (Asia) Pte. Ltd. in Singapore ("TGRD (Asia)") and Millennium Pharmaceuticals Inc. in Cambridge ("Millennium"), wholly owned subsidiaries of Takeda, through outsourcing to contract research organizations. The establishment of TSDC will provide a powerful addition to this global development infrastructure. TSDC will work on extending and enhancing the company's clinical development activities within the Asian region, with a focus on China for General Medicine working as an integrated regional team with TGRD (Asia), and across Asia for Oncology. The team will be composed of personnel from both the Pharmaceutical Development Division and Millennium, and will draw on the rich pool of talent and expertise in China. Through the resources of TSDC, Takeda will continue to conduct high quality clinical trials which will lead to secure regulatory approval in Asia, with a growing emphasis on China, and continue to build deeper relationships with physicians and regulatory authorities.

FDA Approves Subcutaneous Administration of VELCADE® In All Approved Indications

Mark Hollmer — Tue, 24 Jan 2012 13:28:52 -0500

FDA Approves Subcutaneous Administration of VELCADE® In All Approved Indications

- Study met primary efficacy endpoint of non-inferiority between subcutaneous and intravenous administration -

- Study results also indicated overall similar safety profile with differences in incidence of peripheral neuropathy -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE®(bortezomib), which updates the label to include the subcutaneous method of administration in all approved indications: multiple myeloma and mantle cell lymphoma after at least one prior therapy.

"Subcutaneous VELCADE is yet another advance in the management of patients with multiple myeloma or relapsed mantle cell lymphoma"

The approval was based on results from a randomized, phase 3, open-label, international, non-inferiority trial conducted in 222 bortezomib-naïve patients with relapsed multiple myeloma (MM). The primary (non-inferiority) objective of the trial was to demonstrate that single agent subcutaneous VELCADE retained at least 60 percent of the overall response rate (ORR) after 4 cycles relative to single agent intravenous VELCADE. Patients in both arms who did not obtain an optimal response (less than complete response (CR)) to therapy with VELCADE alone after 4 cycles were allowed to receive 20 mg of oral dexamethasone daily on the day of and after VELCADE administration. The secondary endpoints of the study included safety and tolerability, ORR and CR rate after 8 cycles, time to progression (TTP), progression free survival (PFS), and one-year overall survival (OS) of the two routes of administration.

Subcutaneous Administration

The pivotal study, published in the Lancet Oncology in May 2011, met its primary efficacy endpoint. Patients receiving VELCADE subcutaneously achieved a 4-cycle ORR of 43 percent and CR rate of 7 percent, while patients receiving VELCADE intravenously achieved an ORR of 42 percent and a CR rate of 8 percent. The overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, 6 percent of patients experienced PN of grade 3 or higher, compared with 16 percent in the intravenous arm. In the subcutaneous arm, 38 percent of patients experienced PN of all grades, compared with 53 percent of patients in the intravenous arm.

"Subcutaneous VELCADE is yet another advance in the management of patients with multiple myeloma or relapsed mantle cell lymphoma," said Karen Ferrante, M.D., Chief Medical Officer, Millennium. "The consistency in efficacy findings, and observed differences in peripheral neuropathy, allow physicians to tailor VELCADE treatment for their patients."

"Considering this new subcutaneous route of administration for VELCADE is important for our patients, including those with poor vein access and those with pre-existing peripheral neuropathy or a high risk of developing peripheral neuropathy," said Noopur Raje, M.D. director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center. "It's important to have a range of treatment options to provide the best possible care to each individual patient."

Additional study results at 8 cycles of treatment for subcutaneous and intravenous VELCADE, respectively, included:

ORR 53 percent and 51 percent
CR rate 11 percent and 12 percent

Additional study results at 11.8-month median follow-up for subcutaneous and intravenous VELCADE, respectively, included:

TTP 10.4 months and 9.4 months
PFS 10.2 months and 8.0 months
OS at 1 year 72.6 percent and 76.7 percent

Grade 3 and above adverse events with differences greater than 5 percent between routes of administration were:

Peripheral neuropathy, subcutaneous 6 percent, intravenous 16 percent
Thrombocytopenia, subcutaneous 13 percent, intravenous 19 percent
Neuralgia, subcutaneous 3 percent, intravenous 9 percent

New Contraindication for Intrathecal Administration

The updated label also includes a contraindication for intrathecal administration as fatal events have occurred with the inadvertent intrathecal administration of VELCADE. VELCADE is for intravenous or subcutaneous use only.

About VELCADE

VELCADE is co-developed by Millennium and Janssen Pharmaceutical Companies. Millennium is responsible for commercialization of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 300,000 patients worldwide.

Important Safety Information

VELCADE® (bortezomib) is approved for the treatment of patients with multiple myeloma. VELCADE is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.

Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. VELCADE should not be administered intrathecally. Women should be advised not to take VELCADE while pregnant or breast-feeding. Patients with diabetes may require close monitoring and adjustment of their medication.

VELCADE can cause serious side effects, including:

Nerve problems, which can be severe, including muscle weakness, tingling, burning, pain, or loss of feeling in the hands and feet.
A drop in blood pressure resulting in dizziness, light headedness or fainting.
Heart rhythm problems and heart failure including worsening of existing conditions. Symptoms may include chest pressure or pain, palpitations, swelling of the ankles or feet, or shortness of breath.
Lung disorders, some of which have been fatal. Symptoms include cough, shortness of breath, wheezing or difficulty breathing.
Nausea, vomiting, diarrhea and constipation.
Lowering the levels of blood cells, which could result in a higher risk for infections or bleeding.
Tumor lysis syndrome and reversible posterior leukoencephalopathy syndrome have been reported.
Liver failure including a yellow discoloration of the eyes and skin.

Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, insomnia and headache.

These are not all of the possible side effects with VELCADE. Please see the full Prescribing Information for VELCADE for a complete list also available at www.VELCADE.com.

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

Editors' Note: This press release is also available under the Media section of the Company's website at: www.millennium.com/InTheNews.aspx.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Contacts

Millennium: The Takeda Oncology Company
Manisha Pai, +1-617-551-7877
manisha.pai@mpi.com
or
David Albaugh, +1-617-444-4456
david.albaugh@mpi.com
or
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Tel: +81-3-3278-2037

Takeda Announces Strategic Measures to Achieve Efficiencies for Long-Term Growth

Jennifer Levin — Wed, 18 Jan 2012 08:09:13 -0500

Takeda Announces Strategic Measures to Achieve Efficiencies for Long-Term Growth

OSAKA, Japan, January 18, 2012 - Takeda Pharmaceutical Company Limited ("Takeda", TSE: 4502) announced today strategic measures to better align its global workforce and consolidate site operations in order to integrate legacy Nycomed operations, strengthen its presence in more than 70 countries, adapt to changing market conditions and maintain a focus on growth through innovation and culture, as outlined in its 2011-2013 Mid-Range Plan (MRP).

The measures support both the execution of the company's strategy and the integration targets announced last year. They would also bring further efficiencies to the organization to sustain medium and long-term growth targets starting in fiscal 2015. The company will align Nycomed's former operation structures and processes with the Takeda global headquarters in Japan and the newly defined organizations of the Chief Commercial Officer - which is headquartered in Zurich, Switzerland - and Chief Medical & Scientific Officer - which is headquartered in Deerfield, Illinois - and its expanded affiliate network worldwide.

"The combination of Takeda and Nycomed, which we acquired on September 30, 2011, brought together Takeda's strong presence in the Japanese and U.S. markets with the legacy Nycomed business infrastructure in Europe and high-growth emerging markets," said Yasuchika Hasegawa, President & CEO, Takeda Pharmaceutical Company Limited. "While our combined operations in more than 70 countries are more complementary than overlapping, there are a number of areas where we will need to make changes to ensure efficient and flexible operations moving forward."

Takeda will secure a sustainable future by maximizing the synergies of the steady integration of Takeda and Nycomed, such as the sales expansion of Takeda's product pipeline utilizing Nycomed's strong sales platforms in Europe and emerging countries.

To meet the needs of the market, Takeda will also shift from a product portfolio centered on mature, high selling products to a more diverse portfolio focused on new products. The combined company has an active commercial presence in the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.

Takeda also plans to consolidate its R&D sites to ensure ongoing support for all marketed products and support development and global registration of new products throughout the combined footprint. Takeda will invest strongly in R&D focused on core therapeutic areas, while effectively deploying both internal and external resources to create innovative drugs and transform treatment paradigms. The integrated R&D organization aims to support Takeda's global vision of bringing innovative products to address patients' needs by maximizing efficiency, driving standardization, optimizing resource utilization and driving productivity.

To meet its goals, Takeda plans the consolidation of a number of sites and functions, including the potential merger or liquidation of subsidiaries mainly in Europe, and a reduction of workforce in the United States, primarily within Takeda Pharmaceuticals North America. The necessary cost for this plan is estimated approximately Yen 70 billion in total during fiscal 2011 - 2015. During this period, Takeda will achieve cost synergies of approximately Yen 200 billion. The cost synergy in Europe estimated in fiscal 2014 is now Yen 40 billion which is 10 billion greater than the original forecast announced in May 2011. Takeda plans a reduction of the Takeda global workforce by approximately 2,800 (2,100 mainly in Europe and 700 in the U.S.) positions by the end of fiscal 2015 across the functions of R&D, commercial, operations and G&A.

Employees affected by the measures will be offered appropriate guidance and support in accordance with Takeda's corporate values and applicable local practices, policies and requirements.

The financial impact of this plan within fiscal 2011 ending March 2012 is estimated at Yen 35 billion downward in income, and the revised forecast of Takeda's consolidated financial statements, including these strategic measures and other factors, will be disclosed upon fiscal 2011 3Q earnings release announcement scheduled on the 1st February 2012. The updates for progress of consolidation of sites and functions will be announced in an appropriate and timely manner.

These strategic measures and plans announced today are subject to appropriate information and consultation processes with affected employees and their representatives in accordance with applicable national laws on a country by country basis, which commence today.

About Takeda

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

Takeda to Acquire Intellikine, Adding Two Novel Programs to its Oncology Pipeline

Maureen Martino — Wed, 21 Dec 2011 09:09:50 -0500

Takeda to Acquire Intellikine, Adding Two Novel Programs to its Oncology Pipeline

Osaka, Japan, and La Jolla, California, December 20, 2011 - Takeda Pharmaceutical Company Limited (TSE: 4502, "Takeda") and Intellikine, Inc. ("Intellikine") today announced that Takeda America Holdings, Inc., a wholly-owned subsidiary of Takeda, and Intellikine, a privately-held company focused on the discovery and development of innovative, small molecule drugs, have entered into an agreement for Takeda America Holdings to acquire Intellikine by cash. Takeda expects that the transaction will be finalized in January 2012. Under the agreement, Takeda America Holdings will acquire Intellikine for $190 million upfront and up to $120 million in additional potential clinical development milestone payments.

Intellikine has assembled a portfolio of proprietary small molecule kinase inhibitors that selectively target isoforms of the phosphoinositide-3 kinase / mammalian target of rapamycin (PI3K /mTOR ) pathway. The assets of the company include ongoing Phase 1 clinical programs involving selective inhibition of mTOR kinase and isoform-specific inhibition of PI3Ka, as well as a partnered program involving research and development of isoform-specific inhibitors of PI3Kγ/δ, and a robust discovery research platform in small molecule kinase inhibitors. Intellikine's most advanced drug candidate, INK128, a novel mTORC1/2 inhibitor, has generated encouraging data in multiple Phase 1 studies and is expected to enter Phase 2 studies in 2012. INK1117, a novel and selective inhibitor of the PI3Ka isoform, entered human clinical testing in September 2011.

Millennium: The Takeda Oncology Company, Takeda's business unit responsible for global oncology strategy and development, will have global development responsibility for INK128 and INK1117.

"INK128 and INK1117 are potential best-in-class inhibitors of critical pathways driving cancer cell growth," said Deborah Dunsire, M.D., President and CEO, Millennium. "As single agents or in different combinations with novel molecules within our robust pipeline, we anticipate that these assets will be able to deliver transforming therapies to cancer patients."

"Intellikine has advanced three programs against the PI3K/mTOR pathway into human clinical testing in just four years," added Troy Wilson, Ph.D., J.D., President and CEO, Intellikine. "We are pleased that Takeda recognizes the potential of our clinical-stage programs as well as our strong pipeline and discovery engine. Together, with Millennium and Takeda, we can bring the resources and expertise necessary to enable our drug candidates to reach their full potential in the treatment of patients with cancer."

Intellikine's exclusive financial advisor for the transaction was Lazard while Cooley LLP was its legal advisor. Takeda was represented by Covington & Burling LLP.

Takeda does not expect to revise earnings guidance for its 2011 fiscal year in connection with this acquisition.

About Intellikine
Intellikine is a leading private company focused on the development of innovative, small molecule drugs targeting the PI3K/mTOR pathway for the treatment of cancer and other serious diseases. Founded in September 2007, Intellikine has raised $41 million from a group of leading investors, including Sofinnova Ventures, CMEA Capital, Novartis Venture Funds, Abingworth, U.S. Venture Partners, Fintech Global Capital and Biogen Idec.

Corporate Name: Intellikine, Inc.
Location: La Jolla CA
Representative: Troy Wilson, Ph.D., J.D., President and Chief Executive Officer
Year of establishment: 2007
Capital stock: Raised $41M from a group of leading investors, including Sofinnova Ventures, CMEA Capital, Novartis Venture Funds, Abingworth, U.S. Venture Partners, Fintech Global Capital and Biogen Idec.
Shares: Non-listed
Number of employees: 36 total
Relationship with Takeda: no matters to report regarding capital, personal and transactional relationship with Takeda
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com/.

Takeda to Acquire Intellikine, Adding Two Novel Programs to its Oncology Pipeline

Maureen Martino — Wed, 21 Dec 2011 09:02:37 -0500

Takeda to Acquire Intellikine, Adding Two Novel Programs to its Oncology Pipeline

Millennium: The Takeda Oncology Company, Takeda's business unit responsible for global oncology strategy and development, will have global development responsibility for INK128 and INK1117.

Intellikine's exclusive financial advisor for the transaction was Lazard while Cooley LLP was its legal advisor. Takeda was represented by Covington & Burling LLP.

Takeda does not expect to revise earnings guidance for its 2011 fiscal year in connection with this acquisition.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com/.

For all press enquiries please contact:

Seizo Masuda
Takeda Pharmaceutical Company Limited
Public and Investor Relations
+81 3 3278 2037
masuda_seizo@takeda.co.jp

Lindsay Treadway
Millennium: The Takeda Oncology Company
Corporate Communications
+1 617 444-3383
Lindsay.Treadway@mpi.com

Intellikine Contact:
Felicia Vonella
LAS Communications
+1 917 826-3427
felicia@lascommunications.com

Takeda and Affymax Provide Update on Peginesatide Commercialization Rights in Japan

Thu, 15 Dec 2011 16:21:12 -0500

OSAKA, Japan & PALO ALTO, Calif.--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502) and Affymax, Inc. (Nasdaq:AFFY) today announced that Takeda has decided not to commercialize peginesatide in Japan. Peginesatide is an investigational therapy for use in the treatment of patients with anemia due to chronic kidney disease (CKD). Takeda and Affymax will explore other options for the commercialization rights for this product in the Japanese market, including potentially licensing it out to a third party.

Takeda had been reviewing the business opportunity for peginesatide in Japan in view of its product portfolio and also further concentration into its core therapeutic areas and reached the conclusion that commercialization in the territory is not strategically optimal. Takeda and Affymax will continue closely collaborating in the development and commercialization of peginesatide outside Japan, including preparing for potential U.S. approval and launch and regulatory filing in Europe.

In Japan, the majority of phase 2 and phase 3 clinical trials are completed, and the findings to date suggest that peginesatide can become a promising treatment option for Japanese renal anemia patients. Accordingly, the companies are pursuing options that will take the program forward with a regulatory submission and commercialization in Japan.

Takeda and Affymax entered into two agreements signed in 2006 for development and commercialization of peginesatide, one for Japan and another for the rest of the world. In the U.S., a New Drug Application of peginesatide is under FDA review with a scheduled action date of March 27, 2012. In the European Union, Takeda expects to submit a Marketing Authorization Application during the first quarter of calendar year 2012.

About Peginesatide

Peginesatide is a synthetic PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The peginesatide Phase 3 clinical program was the largest to support the new drug application of an ESA in the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events. The compound was discovered by Affymax and is being co-developed by Affymax and Takeda. If approved, peginesatide may be the first once-monthly product for anemia in CKD for dialysis patients available in the United States.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding the timing and potential for FDA approval of peginesatide following the ODAC recommendation, continuation and success of Affymax's collaboration with Takeda, timing for identification of a collaborative partner in Japan, if any, milestones expected to be accomplished, timing, design and progress of the peginesatide development program and the timing and potential regulatory filing of the MAA and commercialization of peginesatide in Europe. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the approvability of the New Drug Application (NDA) filing, risks relating to regulatory requirements and approvals, including pre-or post-marketing studies and Risk Evaluation and Mitigation Strategy (REMS), in particular the FDA's interpretation of the ODAC recommendations and its interpretation and review of the data in the NDA including issues related to the subgroup analyses in non-dialysis, study design, the completeness of the NDA, including data quality and integrity in our non-inferiority designed trials, the continued safety and efficacy of peginesatide in clinical development, the timing of patient accrual in ongoing and planned clinical studies, research and development efforts, industry and competitive environment, potential delays or additional studies that may be required by the FDA or other regulatory authorities, financing requirements and our ability to access capital and other matters that are described in Affymax's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.

About Takeda Pharmaceutical Company Limited

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," “assume,” "continue," "seek," "pro forma," "potential," "target," "forecast," “guidance,” “outlook” or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50108747&lang=en

CONTACT:

Takeda Pharmaceutical Company Limited
Seizo Masuda, +81-3-3278-2037
Corporate Communications Dept. (PR/IR)
or
Affymax, Inc.
Sylvia Wheeler, +1-650-812-8861
Vice President, Corporate Communications

KEYWORDS: United States Asia Pacific North America California Japan

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical

MEDIA:

Logo

Health Canada Approves Feraheme® (ferumoxytol) to Treat Iron Deficiency Anemia in Adults with Chronic Kidney Disease

Mark Hollmer — Mon, 12 Dec 2011 09:30:31 -0500

Health Canada Approves Feraheme® (ferumoxytol) to Treat Iron Deficiency Anemia in Adults with Chronic Kidney Disease

~AMAG Eligible to Receive a $3 Million Milestone Payment from Takeda Related to the First Commercial Sale of Feraheme in Canada~

LEXINGTON, Mass. & MISSISSAUGA, Ontario--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) and Takeda Canada, Inc. ("Takeda") today announced that Health Canada granted marketing approval on December 8, 2011 for Feraheme® (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). Under an agreement with AMAG, Takeda has an exclusive license to market Feraheme for all therapeutic applications in Canada. Upon the first commercial sale of Feraheme in Canada, AMAG will receive a milestone payment of $3 million.

"The approval of Feraheme by Health Canada is an important milestone for AMAG and our efforts to expand its reach to new geographies and broader patient populations," said Frank E. Thomas, chief operating officer and interim president and chief executive officer of AMAG. "To that end, we have marketing applications for ferumoxytol to treat IDA in adult CKD patients currently under review in other regions, including Europe. Additionally, we plan to complete enrollment in a global registration program for the broader indication of iron deficiency anemia in early 2012, which will be the basis for global regulatory filings to expand the indication beyond CKD."

"We are pleased that this approval will provide an effective new treatment option for adults in Canada living with iron deficiency anemia related to their chronic kidney disease," said Mike Egli, General Manager, Takeda Canada, Inc. "We are poised to maximize Feraheme's entry into Canada and are pleased to be able to provide this new treatment option to patients."

Feraheme has been available in the United States for more than two years and has been shown to be safe and effective in improving two key markers of iron deficiency anemia-Hgb and TSAT levels-in both dialysis and non-dialysis dependent CKD patients. In Canada, Feraheme will be administered in two 510 mg IV injections two to eight days apart. The two 510 mg doses can be delivered in under 1 minute each.

According to Health Canada, approximately 1.9 to 2.3 million people are living with CKD, many with iron deficiency anemia.

About AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets Feraheme® in the United States. For additional company information, please visit www.amagpharma.com.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

About Feraheme

In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. For additional product information, please visit www.feraheme.com.

The important safety information below is based on the United States prescribing information.

Important Safety Information About Feraheme

Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.

Warnings and precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience.

In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

Adverse reactions

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥ 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Post-marketing safety experience

The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

For full prescribing information, please visit www.feraheme.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, potential milestone payments and royalties we may receive under our collaboration agreement with Takeda and the expected timing thereof, our expectation that Feraheme will be available in Canada in the second quarter of 2012, our expectation to complete enrollment in our global IDA clinical development program in Q1 2012, and our plans to expand the Feraheme(r) indication beyond CKD and make certain global regulatory filings in connection therewith, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward looking statements.

Such risks and uncertainties include: (1) uncertainties regarding our ability to successfully compete, directly or through our partner Takeda, in the intravenous iron replacement market both in Canada and the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme(r) in new indications and in territories outside of the U.S., (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme(r), (4) the possibility that the FDA or other foreign regulatory authorities could mandate changes to the Feraheme label that would adversely impact the commercial opportunity for Feraheme in the U.S., Canada or other territories, (5) uncertainties regarding our ability to manufacture Feraheme(r), (6) uncertainties relating to our patents and proprietary rights, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2010 and our Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2011. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Takeda to Launch Global Vaccine Business

Maureen Martino — Tue, 06 Dec 2011 10:23:09 -0500

Takeda to Launch Global Vaccine Business

Company to establish Vaccine Business Division and Appoints Dr. Rajeev Venkayya as its Leader

Osaka, Japan, December 5, 2011 - Takeda Pharmaceutical Company Limited ("Takeda") announced today that, effective January 1, 2012, it plans to establish a Vaccine Business Division with the purpose of strengthening the Company's foundations for expansion of its vaccine business on a global scale. The Company also announced the appointment of Dr. Rajeev Venkayya as its leader of the Division.

In Japan, Takeda has established itself as an important supplier of pediatric vaccines for more than 60 years. The Company's recent efforts in vaccine business include clinical testing of the Haemophilus Influenzae type b (Hib) vaccine and development of a combination vaccine containing a Sabin-inactivated poliovirus (s-IPV) vaccine, which is likely to play an important role in polio eradication. Takeda is also developing a human papillomavirus (HPV) vaccine. In order to counter pandemic influenza, Takeda is expediting preparations for production and supply of vaccines against new types of influenza. The acquisition earlier this year of Nycomed A/S, which has a strong business infrastructure in Europe and emerging markets, is expected to support Takeda's initiatives for global vaccine business expansion.

By establishing a Vaccine Business Division, Takeda is determined to contribute to the improvement of public health all over the world as it gathers together and further expands its technology and expertise that have been built over many years. The Vaccine Business Division will take over the ongoing efforts to develop pediatric vaccines in-house and enhance the overall R&D pipeline through the in-license of highly innovative products and novel fundamental technologies. Simultaneously Takeda will pursue viable business opportunities, including alliances supporting the global expansion of the vaccine business.

Assuming office as the head of the new Division on January 15, 2012, Dr. Rajeev Venkayya currently serves as Director of Vaccine Delivery in the Global Health Program at the Bill & Melinda Gates Foundation, where he oversees the Foundation's efforts in polio eradication and its investment in the Global Alliance for Vaccines and Immunization (GAVI). Trained as a physician in pulmonary and critical care medicine, Dr. Venkayya was previously the Special Assistant to the President for Biodefense at the White House. In this capacity he oversaw U.S. preparedness for biological threats, and was responsible for the development and implementation of the National Strategy for Pandemic Influenza.

"While the global vaccine market continues to expand as emerging countries grow, the short supply of affordable vaccines still poses a serious problem. In Japan, the issue of how we should go about ensuring supply of vaccines particularly against emerging infectious threats represents an urgent challenge," said Dr. Tadataka Yamada, Takeda's Chief Medical & Scientific Officer. "Going forward, pharmaceutical manufacturers will be expected to play a critical role in addressing these issues and under the leadership of Dr. Venkayya, Takeda has taken a step forward in fulfilling its responsibility as a leader in the industry."

Affymax and Janssen Biotech Settle Patent Dispute

Wed, 09 Nov 2011 08:21:13 -0500

Ends Ongoing Litigation and Legal Expenses

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today announced that it has reached a global settlement agreement with Janssen Biotech, Inc. (a subsidiary of Johnson & Johnson) and certain of its affiliated companies to end the arbitration and litigation related to certain intellectual property emerging from a 1992-1995 research collaboration.

Under the agreement, Affymax obtains a release of claims, a covenant not to sue and license to the intellectual property in dispute, thereby eliminating potential claims by Janssen regarding the use, manufacture, import, sale and licensing of peginesatide worldwide.

“While we continue to believe in the strength of our position in this intellectual property dispute, we felt it served the best interests of our stockholders to proactively settle the matter to eliminate ongoing legal costs resulting from the litigation and remove any potential hurdles to commercialization of peginesatide for us and our partner Takeda,” said John A. Orwin, chief executive officer of Affymax. “This settlement will allow us to more fully focus our time and resources on the regulatory review process and launch preparations for peginesatide.”

As part of the settlement, Affymax will pay Janssen upfront fees and milestones not to exceed $13 million dollars. Upfront fees consist of two installment payments: $6 million paid immediately and $2 million by June 30, 2012. Milestone payments consist of a $2.5 million payment on U.S. approval of peginesatide and $2.5 million on approval of peginesatide in Europe. As much as half of these amounts are subject to reimbursement by Affymax’s development and commercialization partner, Takeda Pharmaceutical Company Limited. In addition, the settlement provides for Janssen to receive a low single-digit royalty on net sales in the countries of Europe, Mexico, Canada and Japan, until mid-2016. No royalties will be paid on U.S. sales of peginesatide.

In October 2010, Affymax announced the decision of the arbitration panel that reviewed its dispute against Janssen. The panel determined that Affymax and Janssen are co-owners of certain intellectual property, including U.S. patent numbers 5,773,569, 5,830,851, 5,986,047, among others. In addition, the ruling determined that Janssen is sole owner of U.S. patent number 5,767,078 (‘078) and certain other related patents and patent applications in Europe, Japan, Canada, and Australia. The settlement encompasses all of these patents and patent applications.

About Peginesatide

Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. Takeda has exclusive rights to develop and commercialize the product outside the United States. The peginesatide Phase 3 clinical program was the largest to support the registration of an ESA for the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events. The New Drug Application for peginesatide is currently under review at the FDA.

About Affymax, Inc.

This release contains forward-looking statements, including statements regarding the potential implications of the settlement with Janssen Biotech, continuation and success of Affymax's collaboration with Takeda, milestones and reimbursement expected to be received and timing of such payments, timing, design and progress of the peginesatide development program, and the timing and potential regulatory approval and commercialization of peginesatide. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the outcome of our upcoming FDA advisory committee meeting, approvability and completeness of the New Drug Application (NDA) filing, risks relating to regulatory requirements and approvals, in particular the FDA's interpretation and review of the data in the NDA including issues related to the subgroup analyses in non-dialysis, data quality and integrity particularly in non-inferiority designed trials, the continued safety and efficacy of peginesatide in clinical development, industry and competitive environment, other potential intellectual property rights and disputes, financing requirements and ability to access capital and other matters that are described in Affymax's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.

CONTACT:

Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical General Health

MEDIA:

Logo

Affymax® Reports Third Quarter 2011 Financial Results

Wed, 09 Nov 2011 08:21:06 -0500

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today reported financial results for the third quarter ended September 30, 2011. The net loss for the third quarter of 2011 was $9.8 million compared to a net loss of $12.0 million for the third quarter of 2010.

Affymax recognized revenue for the quarter ended September 30, 2011 of $13.2 million compared to $16.8 million for the quarter ended September 30, 2010. During the quarter ended September 30, 2011, we received a $10 million milestone payment from Takeda upon FDA acceptance of our new drug application for review. The decrease in revenue in 2011 was due to decreased reimbursement from Takeda resulting from reduced development expenses.

Research and development expenses for the quarter ended September 30, 2011, were $14.9 million compared to $21.1 million for the quarter ended September 30, 2010. The decrease was due to lower costs for API manufacturing, contractors and consultants in the third quarter of 2011, largely as a result of the submission of our NDA to the FDA for review in the second quarter of 2011.

General and administrative expenses for the quarter ended September 30, 2011 were $8.2 million compared to $7.8 million for the quarter ended September 30, 2010. The increase was primarily due to higher commercial expenses related to expansion of our commercial capabilities.

The company had cash and investments of $116.4 million as of September 30, 2011, which includes the $10 million milestone payment from Takeda upon FDA acceptance of the NDA for peginesatide.

Updated Financial Guidance

Affymax is updating its financial guidance for 2011. With respect to income, Affymax expects total 2011 payments from Takeda to be in the range of $25 million to $30 million, which is at or above the high end of the previously issued range of $20 million to $25 million.

With respect to total operating expenses Affymax expects to incur $95 million to $100 million in operating expenses during 2011, excluding stock-based compensation. This is lower than the previously issued guidance of $105 million to $110 million in operating expenses during 2011, excluding stock-based compensation. This reduction is due largely to the impact of expense reduction efforts as well due to delay in the commencement of Phase 3b studies to evaluate the process and outcomes of converting dialysis centers from a three times per week ESA to once-monthly peginesatide.

As a result, the company expects to end 2011 with approximately $95 million to $100 million in cash, cash equivalents and investments. Affymax continues to expect cash resources, ongoing Takeda reimbursement and milestone payments from Takeda to fund operations through 2012. Under the terms of its 2006 collaboration with Takeda, Affymax is due a $50 million milestone upon approval of the NDA by the FDA.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. Affymax’s product candidate, peginesatide, is currently under FDA review for the treatment of anemia in dialysis patients with chronic kidney disease. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding financial projections and condition, milestones expected to be accomplished, continuation and success of the Company’s collaboration with Takeda, timing, design and progress of the Company’s peginesatide development program and the timing and potential regulatory approval and commercialization of peginesatide. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the approvability and completeness of the New Drug Application (NDA), risks related to regulatory requirements and approvals, in particular the FDA’s interpretation and review of the data in the NDA including issues related to the subgroup analyses in non-dialysis, data quality and integrity particularly in non-inferiority designed trials, risks related to the continued safety and efficacy of peginesatide in clinical development, the potential for once per month dosing and room temperature stability, timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and potential for costs, disruptions and consequences of litigation, financing requirements and ability to access capital, and other matters that are described in Affymax’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.


AFFYMAX, INC.
CONDENSED BALANCE SHEETS
(in thousands)

	September 30,			December 31,
	2011			2010
	(Unaudited)
Assets
Current assets
Cash and cash equivalents	$	66,025		$	63,499
Short-term investments		49,222			33,582
Receivable from Takeda		5,452			—
Deferred tax assets		438			438
Prepaid expenses and other current assets		1,753			2,023
Total current assets		122,890			99,542
Property and equipment, net		3,071			3,982
Restricted cash		1,135			1,135
Long-term investments		—			19,876
Deferred tax assets, net of current		6,802			6,802
Other assets		351			50
Total assets	$	134,249		$	131,387
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	2,579		$	321
Accrued liabilities		11,359			11,594
Accrued clinical trial expenses		3,251			11,247
Payable to Takeda		—			5,958
Deferred revenue		—			18,497
Total current liabilities		17,189			47,617
Long-term income tax liability		10,378			10,249
Advance from Takeda		2,835			—
Other long-term liabilities		914			974
Total liabilities		31,316			58,840
Commitments and contingencies (Note 7)

Stockholders’ equity
Common stock: 35,645,926 and 25,451,338 shares issued and outstanding at September 30, 2011 and December 31, 2010, respectively		36			25
Additional paid-in capital		523,715			461,425
Accumulated deficit		(420,860	)		(388,934	)
Accumulated other comprehensive income		42			31
Total stockholders’ equity		102,933			72,547
Total liabilities and stockholders’ equity	$	134,249		$	131,387


AFFYMAX, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2011			2010			2011			2010
Revenue:
Collaboration revenue	$	13,204		$	16,784		$	44,029		$	105,771
License and royalty revenue		5			6			14			15
Total revenue		13,209			16,790			44,043			105,786
Operating expenses:
Research and development		14,863			21,118			51,606			83,120
General and administrative		8,172			7,781			24,426			25,372
Total operating expenses		23,035			28,899			76,032			108,492
Loss from operations		(9,826	)		(12,109	)		(31,989	)		(2,706	)
Interest income		45			47			136			227
Interest expense		(38	)		(35	)		(111	)		(104	)
Other income (expense), net		3			67			39			(1	)
Net loss before provision for income taxes		(9,816	)		(12,030	)		(31,925	)		(2,584	)
Provision for income taxes		—			—			(1	)		—
Net loss	$	(9,816	)	$	(12,030	)	$	(31,926	)	$	(2,584	)
Net loss per share:
Basic and diluted	$	(0.28	)	$	(0.49	)	$	(0.98	)	$	(0.11	)
Weighted-average number of shares used in computing basic and diluted net loss per share		35,578			24,369			32,474			24,168

CONTACT:

Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical FDA

MEDIA:

Logo