Exits

Zymeworks Announces Bi-Specific Antibody Collaboration with Celgene

January 21, 2015

Vancouver, Canada (January 21, 2015) – Zymeworks Inc. today announced a collaboration and licensing agreement with Celgene Corp. for the research, development, and commercialization of bi-specific antibody therapeutics enabled using Zymeworks’ proprietary Azymetric™ platform.

Under the terms of the agreement, Zymeworks and Celgene will collaborate on the research and development of multiple bi-specific antibodies based on the Azymetric™ platform. Celgene will have the option to advance the resulting bi-specific candidates through clinical development and subsequent commercialization. Zymeworks will receive an initial upfront payment, as well as an equity investment from Celgene. Zymeworks is eligible to receive clinical, regulatory, and commercial milestones on successful candidates totaling up to US $164M per therapeutic candidate. Additionally, Zymeworks will receive royalties on worldwide net sales. Further financial details are not disclosed.

“We are extremely excited to collaborate with Celgene on the development of bi-specific antibodies using the Azymetric™ platform and believe that this class of biotherapeutics has the potential to create game-changing treatment options for patients with unmet medical needs,” said Ali Tehrani, Ph.D., President & CEO of Zymeworks. “We believe that the upfront revenue from this collaboration, in combination with Celgene’s meaningful equity investment and the proceeds from our recent financing rounds, will help accelerate Zymeworks’ internal oncology pipeline candidates towards multiple INDs in 2016 and beyond.”

About the Azymetric™ Platform

Bi-specific antibodies developed using the Azymetric™ platform resemble conventional mono-specific antibodies while being able to simultaneously bind to two different targets resulting in additive or synergistic therapeutic responses. Azymetric™ antibodies spontaneously assemble into a single molecule with two different Fab domains comprising of unique heavy and light chain pairings. Azymetric™ antibodies are manufactured using conventional monoclonal antibody processes and can also be easily adapted to rapidly screen target and sequence combinations for bi-specific activities in the final therapeutic format thereby significantly reducing drug development timelines.

About Zymeworks Inc.

Zymeworks is a privately held biotherapeutics company that is developing best-in-class Azymetric™ bi-specific antibodies and antibody drug conjugates for the treatment of oncology, autoimmunity and inflammatory diseases. The company’s novel Azymetric™ and AlbuCORE™ platforms, and its proprietary ZymeCAD™ structure-guided protein engineering technology, enable the development of highly potent bi-specific antibodies and multivalent protein therapeutics targeted across a range of indications. Zymeworks is focused on accelerating its preclinical biotherapeutics pipeline through in-house research and development programs and strategic collaborations. More information on Zymeworks can be found at www.zymeworks.com.

Contact

David Poon, Ph.D.
Zymeworks Inc.
Senior Director, External R&D and Alliances
Phone: 604 678-1388
Email: info@zymeworks.com

Source: Zymeworks Inc.

Medicago announces agreement to be acquired by Mitsubishi Tanabe Pharma in a transaction valued at $357M

Quebec City, July 12, 2013 – Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced today that it has entered into a definitive arrangement agreement with Mitsubishi Tanabe Pharma Corporation (“Mitsubishi Tanabe Pharma” or “MTPC”) whereby MTPC will acquire all of the issued and outstanding common shares (“Shares”) of Medicago, other than the Shares currently held by Philip Morris Investments B.V. (“PMI”) an affiliate of Philip Morris International Inc. and MTPC, for $1.16 in cash per Share (the “Purchase Price”).  Upon completion of the transaction, Medicago will be jointly owned by MTPC (60%) and PMI (40%).

 

The Purchase Price represents a premium of approximately 22.1% to the closing price of $0.95 per Share on the TSX on July 11, 2013 and a premium of approximately 46.8% and 61.1% over the 30-day and 90-day volume weighted average prices of $0.79 and $0.72 per Share on the TSX, respectively, up to and including July 11, 2013.  The transaction represents a total enterprise value of approximately $357 million, including the assumption of existing indebtedness, for 100% of Medicago.

 

The transaction has been approved unanimously by the Board of Directors of Medicago following the unanimous recommendation of a Special Committee of Independent Directors. The Board of Directors of Medicago also unanimously recommends that shareholders vote in favour of the transaction at the special meeting of shareholders to be called to approve the transaction. PMI, Medicago’s principal shareholder, which currently holds 38.5% of all issued and outstanding Shares of Medicago, has agreed to irrevocably support and vote its Shares in favour of the transaction until April 12, 2014. In addition, all directors and certain officers of Medicago holding approximately 1.6% of the issued and outstanding Shares have also entered into agreements pursuant to which they have agreed to vote their Shares in favour of the transaction.

 

“Mitsubishi Tanabe Pharma, a top 30 global pharmaceutical company, has been a solid and committed partner with the ability to drive Medicago’s future growth and success in the development of our best-in-class rapid plant-based vaccines,” said Andy Sheldon, President and CEO of Medicago. “Mitsubishi Tanabe Pharma’s capabilities in biopharmaceutical research, development, and commercialization along with its financial stability offer us the ideal opportunity to realize the full potential of our platform. These resources provide us the ability to foster the development of innovative vaccines with the financial stability to expand our Quebec, Canadian, U.S. and global operations.”

 

“Building on our existing collaboration, we look forward to working with the management and employees of Medicago to further develop the business and advance their promising work,” said Michihiro Tsuchiya, Representative Director of Mitsubishi Tanabe Pharma Corporation.  “We are proud to invest in developing novel vaccines in Québec City and North Carolina as part of our global operations.”

 

Fairness Opinions and Formal Valuation

TD Securities Inc. (“TD Securities”), as financial advisor to Medicago, and Desjardins Capital Markets (“Desjardins”), as independent valuator to the Special Committee, have each provided an opinion to the Special Committee and Board of Directors of Medicago that, subject to the assumptions, qualifications and limitations provided therein, the consideration to be received by the shareholders (other than MTPC and PMI) under the arrangement is fair, from a financial point of view, to such shareholders. Desjardins has also provided the Special Committee with a formal valuation completed under the supervision of the Special Committee, as contemplated by Regulation 61-101 Protection of Minority Security Holders in Special Transactions (“Regulation 61-101”), and which concludes that, subject to the assumptions, qualifications and limitations therein, the fair market value of the Shares is between $1.05 and $1.35 per Share.

 

Transaction Details

The completion of the transaction is subject to court approval pursuant to the Business Corporations Act (Québec) and the approval of Medicago’s shareholders. The transaction is subject to Regulation 61-101 and the implementation of the arrangement will be subject to the approval of 66 2/3% of the votes cast by shareholders present in person or by proxy at the special meeting of shareholders of Medicago and by holders of more than 50% of the votes cast by Medicago’s minority shareholders being all shareholders excluding MTPC, PMI and any of their respective affiliates. The Company intends to mail a management information circular in the upcoming weeks to its shareholders for a meeting expected to be held before August 30, 2013. The transaction is also subject to customary closing conditions, including receipt of all regulatory approvals, and is expected to close later this calendar year. The transaction is not subject to any financing condition.

 

The arrangement agreement provides for, among other things, a non-solicitation covenant on the part of Medicago subject to customary fiduciary out provisions. The arrangement agreement also provides MTPC with a “right to match” and requires Medicago to pay a termination fee in the amount of $9.25 million under certain circumstances.  MTPC has agreed to pay Medicago a termination fee of $9.25 million if the transaction is not completed as a result of a breach of representations or covenants by MTPC. MTPC has also agreed to reimburse Medicago’s expenses related to the transaction, up to an amount of $1,500,000, in the event the transaction does not close as a result of certain regulatory approvals not being obtained.

 

Upon closing of the transaction, holders of warrants and stock options of Medicago will receive a cash payment equal to the difference between $1.16 and the exercise price of such warrant or stock options.

 

MTPC has also agreed, subject to the necessary regulatory approvals being secured, to make available to Medicago a non-interest bearing loan in a principal amount not to exceed $13.5 million in three instalments for the purpose of providing Medicago with adequate cash liquidity until closing of the transaction should closing not have occurred by September 15, 2013.  In the event the arrangement agreement is terminated and the transaction does not close, the loan will become due and payable, and Medicago will satisfy its obligations to repay the loan through the issuance of Shares to MTPC at a price of $0.82 per Share.

 

Further details regarding the terms of the transaction are set-out in an Arrangement Agreement which will be available under the profile of Medicago at www.sedar.com.

 

Advisors

TD Securities is financial advisor to Medicago in connection with the transaction and Desjardins Capital Markets acted as independent valuator to the Special Committee of Medicago. McCarthy Tétrault LLP is Medicago’s legal counsel. MTPC’s financial advisor is Goldman Sachs and its legal counsel are Stikeman Elliott LLP and Ropes & Gray LLP.

 

About Medicago

Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases worldwide. The Company is committed to providing highly effective and competitive vaccines and therapeutic proteins based on its proprietary VLP and manufacturing technologies. Medicago is a worldwide leader in the development of VLP vaccines using a transient expression system which produces recombinant vaccine antigens in plants. This technology has potential to offer more potent vaccines with speed and cost advantages over competitive technologies, enabling the development of a vaccine for testing in approximately one month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic, and supply large volumes of vaccine antigens to the world market. Medicago also intends to expand development into other areas such as biosimilars and biodefense products where the benefits of our technologies can make a significant difference. Additional information about Medicago is available at www.medicago.com.

 

About Mitsubishi Tanabe Pharma

Mitsubishi Tanabe Pharma is a research-driven pharmaceutical company based in Japan, specializing in research, development and marketing of globally competitive pharmaceutical products focused on the field of autoimmune disease, diabetes and kidney disease, and CNS disease.  Mitsubishi Tanabe Pharma contributes to the healthier lives of people around the world through the creation of pharmaceuticals that respond to unmet medical needs. 
Additional information about MTPC is available at http://www.mt-pharma.co.jp/e

Closing of acquisition of Enobia by Alexion – Yet another successful portfolio exit for CTI’s Life Sciences Fund

Montreal, February 10, 2012 – CTI Life Sciences Fund (CTI) is happy to confirm the closing of the previously announced transaction of Thursday, December 29, 2011, whereby Alexion Pharmaceuticals (Alexion) proposed to acquire the Montreal Corporation, Enobia Pharma (Enobia), a CTI portfolio holding, of which it is a major shareholder. Pursuant to the terms set out in the Merger Agreement, Alexion paid out $US 610 million upon consummation of the transaction. In addition, a supplementary amount of up to $US 470 million in cash, could be paid out based on Enobia’s lead product, ENB-0040 (asfotase alfa), achieving various regulatory and commercial milestones. ENB-0040 completed Phase II clinical studies already demonstrating promising results.

 
This molecule, which targets defective bone mineralization of patients by correcting an inborn genetic defect was designed in the Université de Montréal laboratories through the work of professor Philippe Crine. This molecule was developed by Enobia to treat patients suffering from hypophosphatasia (HPP); an ultra-rare, life threatening, genetic metabolic disease for which there are no approved treatment options. This rare disease, with debilitating morbidities such as skeletal deformity, severe muscle weakness, and progressive damage to vital organs, affects a very small portion of the Canadian population and was identified by Canadian scientific researchers.
 
“Enobia is a result of the creative value added process, to which CTI is totally committed to, based on the investment strategy it announced at the Fund’s inception in 2006”, declared Richard Meadows, Managing Partner of CTI and Board Member of Enobia. “The CTI team was able to identify, at an early stage (the pre-clinical phase), the promising potential linked to the ENB-0040 compound; it was also able to rally an American investor, Orbimed Advisors, known for its substantial financial resources and contacts, but foremost for its exceptional experience in rare diseases. The combination of these two important factors, allowed CTI to conduct in partnership, a new financial round and to help drive the successful development of this project.” Shermaine Tilley, Ph.D, MBA, a CTI Partner, also greatly contributed to this project by acting as an observer on the Board of Directors of Enobia.
 
About CTI Life Sciences Fund
Based in Montreal, CTI Life Sciences Fund L.P. is a limited partnership formed in 2006. The Fund specializes in venture capital investments primarily in Canada, targeting high quality emerging life sciences companies at the start-up and clinical development stages. This Fund is the first of its kind created in Québec since 2002.
 
CTI Life Sciences Fund L.P. has secured $100 million in commitments from Québec institutional investors such as the Caisse de dépôt et placement du Québec, Fonds de solidarité des travailleurs du Québec (F.T.Q.), FIER Partners L.P., Régime de rentes du Mouvement Desjardins and CTI Capital Group’s partners.
 
The CTI Life Sciences Fund L.P. team of professionals in science and finance has extensive experience in the biotechnology and the pharmaceutical industries. The Fund works closely with entrepreneurs and researchers to increase the value of these emerging companies.

Alexion to Acquire Enobia Pharma Corp. and First Potential Treatment for Patients with Hypophosphatasia (HPP)

Cheshire, CT, December 28, 2011 – Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Enobia Pharma Corp. today announced that the companies have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia. Enobia is a private biopharmaceutical company based in Montreal, Canada and Cambridge, Massachusetts, which is focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders.

 

Enobia’s lead product candidate ENB-0040 (asfotase alfa), is a human recombinant targeted alkaline phosphatase enzyme-replacement therapy for patients suffering with hypophosphatasia (HPP), an ultra-rare, life-threatening, genetic metabolic disease for which there are no approved treatment options. Alexion will acquire full worldwide development and commercial rights to asfotase alfa. Asfotase alfa was awarded orphan drug designation in the U.S. and EU in 2008 and Fast Track status in the U.S. in 2009, and is currently in Phase II clinical development.

 

“Hypophosphatasia is an ultra-rare and life-threatening disease, and those patients who survive live with debilitating morbidities including skeletal deformity, severe muscle weakness, and progressive damage to vital organs,” said Leonard Bell, M.D., Chief Executive Officer of Alexion. “Asfotase alfa has shown very compelling Phase II clinical data in infants and juveniles with hypophosphatasia. The acquisition of Enobia is very well aligned with Alexion’s objective to develop and deliver life-transforming therapies for patients suffering with ultra-rare, severe, and life-threatening disorders.”

 

“Alexion has proven expertise in developing and commercializing therapies to transform the lives of patients with severe and ultra-rare disorders, making them the ideal partner to advance the work of the Enobia team and bring asfotase alfa to HPP patients around the world,” said Jonathan Silverstein, General Partner of OrbiMed and Enobia Chairman. OrbiMed is a controlling shareholder in Enobia.

 

“Enobia and our scientific collaborators have developed an elegant compound showing very promising clinical results to date,” said Dr. Robert Heft, President and Chief Executive Officer of Enobia. “Together with Alexion, we share a sharp focus on transforming the lives of patients with severe and ultra-rare disorders. The hypophosphatasia patient community will be well served by the experience and international scope of Alexion.”

 

The Transaction

Alexion will acquire Enobia in an all-cash transaction. Under the terms of the agreement, Alexion has agreed to pay $610 million in cash upon consummation of the transaction, and up to $470 million in cash to be paid upon achievement of various regulatory and sales milestones. Alexion is not issuing equity in connection with the acquisition. The transaction is subject to customary conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The Boards of both companies have approved the transaction and the companies currently anticipate that the transaction will be completed in the first quarter of 2012. Alexion intends to finance the acquisition through cash on hand and $300 million of committed bank debt. Goldman, Sachs & Co. is acting as financial advisor to Alexion. Ropes and Gray LLP is acting as legal counsel to Alexion. Bank of America Merrill Lynch is acting as financial advisor to Enobia. WilmerHale is acting as legal advisor to Enobia.

 

About Hypophosphatasia (HPP)

HPP is an ultra-rare, genetic, and life-threatening metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation leading to progressive damage to multiple vital organs including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure.1,2,3,4 The severe manifestations of the genetic deficiency in HPP affect people of all ages, and approximately 50 percent of infants with the disease do not survive past one year of age.1 HPP is caused by a genetic deficiency of an enzyme known as tissue non-specific alkaline phosphatase (TNSALP), which causes life-long abnormalities in metabolism of the two vital minerals calcium and phosphate, leading directly to the debilitating morbidities and premature mortality of the disease.1 There are currently no therapies approved for HPP.1

 

About Asfotase Alfa

Asfotase alfa is an investigational, highly innovative, first-in-class recombinant protein that addresses the underlying cause of HPP by targeting replacement of the missing enzyme to the necessary body tissues. Asfotase alfa is designed to normalize the genetically defective metabolic process and prevent or reverse the severe and life-threatening complications of life-long dysregulated mineral metabolism in patients with HPP.

 

2012 Initial Financial Outlook

Alexion will provide 2012 financial guidance in February, including one-time expenses related to the Enobia acquisition. 2012 non-GAAP research and development expenses are expected to transiently rise to approximately 20 to 21% of sales, due to activities associated with Enobia’s programs, and then to return to the Company’s target of approximately 17% to 18% of sales in 2013. Non-GAAP selling, general and administrative expenses associated with the proposed acquisition are expected to have limited impact in 2012. Alexion is reiterating all areas of 2011 guidance provided in its third quarter 2011 earnings announcement in October.

 

Conference Call Information

Alexion will host a conference call tomorrow, December 29 at 9:00AM Eastern Time, to discuss the proposed acquisition. To access the live call, please dial 1-888-297-0356 (U.S.) or 1-719-325-2109 (international). The conference passcode number is 5470489. Telephone replay will be available for a limited period following the call, beginning at 12:00PM Eastern Time. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), confirmation code 5470489. The audio webcast can be accessed at www.alexionpharma.com.

 

About Enobia Pharma Corp.

Enobia Pharma Corp., based in Montreal, Canada, and Cambridge, Massachusetts, is a privately held clinical stage biotech company focused on developing novel therapeutics for serious metabolic bone disorders. The Company’s largest investors include OrbiMed, Fonds de Solidarité des Travailleurs du Québec (F.T.Q.), Capital Régional et Coopératif Desjardins, CTI Life Sciences Fund, L.P., and Lothian Partners 27 (Sarl) SICAR. For more information, please visit www.enobia.com.

 

About Alexion

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 35 countries for the treatment of PNH, and in the United States and the European Union for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.

Zymeworks Snags $187M Deal With Merck to Discover Multi-Pronged Antibodies

Vancouver, BC, August 29, 2011 – Merck has made plain that it needs to elevate its game in biotech drug development, and that means turning to partners for help. The latest chapter in this ongoing story is now unfolding at a little company called Zymeworks in Vancouver, BC.

 

Zymeworks is announcing today it has secured a partnership with Whitehouse Station, NJ-based Merck (NYSE: MRK) to develop new antibody drugs for cancer and autoimmune diseases that are engineered to hit two or more targets on cells instead of just one. In exchange for helping Merck create these so-called “bispecific” antibodies, Zymeworks is getting an undisclosed cash fee upfront, plus milestone payments, which could be worth as much as $187 million over time if drugs from the partnership reach certain goals. Merck will have exclusive worldwide rights to sell drugs from the partnership and Zymeworks will get tiered royalties on product sales if any materialize.

 

The deal is part of Merck’s long term plan to catch up in the business of biotech drug development. Estimates are that eight of the world’s 10 best-selling drugs in 2014 will be biologic medicines, leaving only two compounds made from chemical synthesis—Merck’s historic wheelhouse. The pharma giant has leaned on another startup, Lebanon, NH-based Adimab, as a source of antibody drug candidates, and it has spoken publicly about its growing ability to make antibodies at its GlycoFi facility and in facilities obtained through its Schering-Plough mega-merger of 2009. But the Zymeworks deal represents a chance for Merck to move into a hot area of protein drug engineering that biotech leaders like Genentech, Amgen, and Biogen Idec have been pursuing for years. “We didn’t invent the field of rational protein engineering, but we have stepped up to take it to the next level,” says Zymeworks founder and CEO Ali Tehrani.

 

Zymeworks, founded in 2003, has developed a technology for creating lots of custom-designed protein drug candidates with properties drug developers want. The system can be used to make potent proteins that can last longer in the bloodstream, enabling patients to take fewer injections. Zymeworks can also engineer in specific structures that can make an antibody bind specifically and tightly with one or two different targets of interest on diseased cells. And it says the technology can be used to alter proteins to induce what’s known as “effector function,” which basically means that they can be made to trigger an immune system reaction which could give a cancer drug an extra potent boost. The company spent its first four years trying to develop this technology to make industrial enzymes, until it saw bigger market potential in the pharmaceutical business, Tehrani says. “We could have been a mom and pop, coffee shop type of business,” he says.

 

Zymeworks now has ambitions to become a drug developer of its own, not just a technology provider to Merck and a few other partners, Tehrani says. The company still has a long way to go on that expensive journey. It has 37 employees, has raised less than $15 million through its history from Montreal-based CTI Life Sciences Fund, the Canadian government, and private investors. It hasn’t yet entered clinical trials with any drug candidates. But Tehrani, who got his microbiology and immunology doctorate from the University of British Columbia, says Zymeworks grabbed the attention of Merck and other prospective partners with “solid” data from experiments with its protein drugs in petri dishes.

 

Zymeworks certainly isn’t the only startup out there with visions of developing better versions of today’s protein drugs. Seattle-based Allozyne, San Diego-based Ambrx, South San Francisco-based Sutro Biopharma, and South San Francisco-based CytomX Therapeutics are just a few startups in that space along with many of the traditional biotech giants mentioned above. Zymeworks seeks to differentiate itself a couple different ways, Tehrani says. One is that it has software to better characterize the properties of the drug candidates, which ought to help researchers predict how they will perform in clinical trials. The other key feature is that Zymeworks can engineer its properties into immunoglobulin class-1 proteins, which Tehrani says offers an advantage over other techniques in manufacturing.

 

Zymeworks’ long-term goal, Tehrani says, is to grow up to be like Applied Molecular Evolution, a San Diego-based protein engineering company acquired by Eli Lilly for $400 million in 2004. Zymeworks had interest from several partners in its technology, Tehrani says, but chose Merck for a few reasons. First, Merck provided enough validation of the technology, and upfront cash, to help stir up some more interest among investors in putting more capital into the company, Tehrani says. Plus, Merck’s development capabilities at its Palo Alto, CA-based biologics facility were a cut above facilities from other companies, he says. “We are protein engineers. They are drug developers with a detailed understanding of biologics,” Tehrani says. “We see a long term strategic collaboration.”

Sanofi-Aventis to acquire TargeGen Inc., a US biopharmaceutical company

Paris, France,  June 30, 2010 – Sanofi-Aventis (EURONEXT: SAN and NYSE: SNY) announced today that it has signed an agreement for the acquisition of TargeGen Inc., (“TargeGen”) a privately held US biopharmaceutical company developing small molecule kinase inhibitors for the treatment of certain forms of leukemia, lymphoma and other hematological malignancies and blood disorders.

 

Under the terms of the agreement, Sanofi-Aventis will make an upfront payment of $75 million upon closing of the transaction. Further milestones payments will occur at different stages of development of TargeGen lead product TG 101348. The total amount of all payments, including the upfront payment, could reach US $ 560 million. The closing of the transaction is expected to occur in the 3rd quarter of 2010 and is subject to customary consent conditions.

 

“Sanofi-Aventis brings many strengths to the continued development and potential commercialization of TG101348”, said Peter G. Ulrich, President and Chief Executive Officer and Co-Founder of TargeGen. “With their global focus on oncology and long term commitment to this patient population, we are confident they will maximize the potential of TG101348 across multiple clinical indications” .

 

“The acquisition of TargeGen represents a further significant step to increase our engagement in the field of hematological malignancies”, declared Marc Cluzel, M.D., Ph.D, Executive Vice-President, Research & Development, Sanofi-Aventis. “In addition, this acquisition is another example of our strong commitment to oncology to provide patients, physicians and public health stakeholders with breakthrough medicines addressing unmet medical needs.”

 

TG 101348, is a potent inhibitor of Janus kinase 2 (JAK-2). It is an oral agent and is being developed for the treatment of patients with myeloproliferative diseases including myelofibrosis (MF). MF is a chronic and progressive disorder in which there is a proliferation of certain cells of the bone marrow resulting in bone marrow fibrosis and is associated with activating mutations of JAK-2. TG 101348 has completed a multicenter clinical Phase 1/2 trial in patients with myelofibrosis. Additional clinical studies are planned to start in the second half of 2010.

 

Besides MF, TG 101348 could be effective in a variety of other hematological malignancies, such as Polycythemia Vera (PV), a blood disorder in which the bone marrow produces too many red blood cells. Currently, there are no approved or adequately effective therapies to treat these diseases called myeloproliferative neoplasms that are estimated to affect around 400,000 patients in the United States and in Europe.

 

About Myeloproliferative Neoplasms

Myeloproliferative Neoplasms is a group of disesases that include Myelofibrosis, Polycythemia Vera, and Essential thrombocythemia. Myelofibrosis (MF) is a disease in which the proliferation of an abnormal type of bone marrow stem cell results in fibrosis. Polycythemia Vera (PV) is a blood disorder in which the bone marrow produces too many red blood cells. PV may also result in the overproduction of white blood cells and platelets. Most of the health concerns associated with PV are caused by a blood-thickening effect that results from an overproduction of red blood cells. Essential thrombocythemia (ET) is a chronic blood disorder characterized by the overproduction of platelets by megakaryocytes in the bone marrow. In some cases this disorder may be progressive and evolve into acute myeloid leukemia or MF.

 

About TargeGen

TargeGen is a privately held US biopharmaceutical company based in San Diego, CA, USA, developing small molecule kinase inhibitors for the treatment of hematological malignancies and certain other disorders. In addition to TG 101348, the company also has additional tyrosine kinases in pre-clinical development. For more information, please visit: www.targegen.com.

 

About Sanofi-Aventis

Sanofi-Aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-Aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com.