8/16/2011

Boehringer Ingelheim Licenses ProBioGen’s GlymaxX Technology

Boehringer Ingelheim and ProBioGen AG recently announced they have signed a non-exclusive Licensing Agreement regarding ProBioGen’s GlymaxX technology. Boehringer Ingelheim’s Contract Manufacturing Business will apply the technology to enhance ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity of antibodies.

The GlymaxX technology for production of afucosylated proteins is universally applicable, simple, and potent. As a unique feature, differentiating it from other approaches, the GlymaxX technology can also be applied to already existing antibody producer cell lines without altering their productivity. The technology can easily be integrated into Boehringer Ingelheim’s high expression CHO-based BI-HEX system. Both Parties agreed to jointly market the technology and to offer it to customers royalty free.

“We are very pleased that Boehringer Ingelheim has decided to integrate our GlymaxX technology into their technology portfolio for customer and in-house projects. This is an additional milestone in our long-standing business relationship,” said Volker Sandig, Chief Scientific Officer of ProBioGen AG.

“The GlymaxX technology is another demonstration of ProBioGen’s core expertise, understanding animal cell biology, and converting this knowledge into pioneering solutions in process development and product design,” added Wieland Wolf, ProBioGen’s Chief Executive Officer.

“With the combination of the BI-HEX platform and ProBioGen’s GlymaxX technology, we can offer our customers tailored solutions for high titer expression of highly potent antibodies,” explained Simon Sturge, Corporate Senior Vice President Biopharmaceuticals of Boehringer Ingelheim. “This is another step to continuously invest in our technology leadership and to provide flexible solutions, addressing our customer’s needs.”

ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity is an important antibody function leading to selectively killing target cells, ie, cancer cells or pathogen-infected cells. Several therapeutic antibody drugs on the market rely on ADCC as a mechanism of action. ADCC enhancement has the potential to increase the therapeutic effect and/or to greatly reduce antibody dosage requirements, resulting in fewer side-effects and treatment costs.

The GlymaxX technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose enhances ADCC. The GlymaxX technology is based on the introduction of a gene for an enzyme that deflects the cellular pathway of fucose biosynthesis. The GlymaxX technology is universally applicable, simple, and potent, and can be rapidly applied to any existing antibody producer cell line, or can be included into any new cell line development. ProBioGen offers this technology royalty-free to third parties.

ProBioGen is an internationally operating Contract Development and Manufacturing Organization (CDMO) with almost 20 years of experience in mammalian cell culture, process development, and GMP-manufacturing. The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates in 50 countries and more than 42,000 employees. Today, Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacture of biopharmaceuticals.

Array BioPharma, Genentech Ink $713 Million Oncology Pact

Array BioPharma recently announced an oncology agreement with Genentech, a member of the Roche Group, for the development of each company’s small-molecule Checkpoint kinase 1 (ChK-1) program. The programs include Genentech’s compound GDC-0425 (RG7602), currently in Phase I, and Array’s compound ARRY-575, which is being prepared for an INDA to initiate a Phase I trial in cancer patients.

Under the terms of the agreement, Genentech is responsible for all clinical development and commercialization activities. Array will receive an up-front payment of $28 million and is eligible to receive clinical and commercial milestone payments up to $685 million and up to double-digit royalties on sales of any resulting drugs. Full financial terms have not been disclosed.

“We’re delighted to expand our long-standing relationship with Genentech, a leading innovator of important new cancer therapies,” said Robert E. Conway, Chief Executive Officer, Array BioPharma. “Combining both companies’ programs will maximize our chances for success in developing and commercializing this novel cancer therapy. We believe ChK-1 inhibition is a key strategy for enhancing the efficacy of chemotherapeutic and other agents in cancer patients.”

ChK-1 is a protein kinase that regulates the tumor cell’s response to DNA damage often caused by treatment with chemotherapy. In response to DNA damage, ChK-1 blocks cell cycle progression in order to allow for repair of damaged DNA, thereby limiting the efficacy of chemotherapeutic agents. Inhibiting ChK-1 in combination with chemotherapy can enhance tumor cell death by preventing these cells from recovering from DNA damage. Both GDC-0425 and ARRY-575 are highly selective, oral ChK-1 inhibitors designed to enhance the efficacy of some chemotherapeutic agents.

Genentech and Array have worked together since 2004 to advance certain oncology programs into clinical development. In 2010, one resulting drug, GDC-0068, an AKT inhibitor, entered Phase I clinical testing. GDC-0068 is currently advancing into a Phase Ib trial. Array researchers continue to advance other preclinical programs under Array’s collaboration agreement with Genentech.

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Its proprietary drug development pipeline includes clinical candidates designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs.

Affymax Receives $10-Million Milestone Payment From Takeda

Affymax, Inc. recently announced it has received a $10-million development milestone payment from Takeda Pharmaceutical Company as part of the companies’ exclusive global agreement to develop and commercialize peginesatide (formerly known as Hematide), Affymax’s investigational drug for the treatment of anemia in chronic renal failure patients. The payments were triggered by the acceptance and filing of the NDA for peginesatide by the FDA.

If approved, peginesatide will be the first once-monthly erythropoiesis-stimulating agent (ESA) available for the treatment of anemia associated with CKD patients on dialysis in the United States.

Affymax and Takeda Pharmaceutical North America are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. The product, upon approval, will be commercialized outside the United States by Takeda. The peginesatide Phase III 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.

Anemia is a common complication in CKD because the impaired kidneys are not able to produce enough erythropoietin, the hormone that promotes the production of oxygen-carrying red blood cells. Research has shown that anemia impacts the overall health and well being of CKD and dialysis patients and is associated with increased rates of hospitalization and mortality. In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs. ESAs, which stimulate red blood cell production, are commonly prescribed to treat anemia of CKD. According to the Centers for Medicare and Medicaid Services, more than 95% of patients on dialysis in the United States are currently receiving ESA treatment for anemia of CKD.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions.

Nycomed & Orion Corporation to Collaborate on Easyhaler

Nycomed recently announced it has entered into a collaboration agreement with Orion Corporation for the co-marketing of Easyhaler combination products for the treatment of asthma and COPD in the major European countries and an exclusive license and distribution arrangement for the Middle East and North Africa region (MENA). Both companies will commercialize Easyhaler combination products under their own brands accompanied by the Easyhaler umbrella brand.

The agreement covers Orion’s new Easyhaler combination products for treatment of asthma and COPD. Orion is developing a budesonide-formoterol formulation that combines budesonide as an anti-inflammatory agent and formoterol as a long-acting bronchodilator. In addition, Orion has another Easyhaler research program in progress to develop a fluticasone-salmeterol formulation. In this formulation, fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator. Both these combination products are included in the co-marketing agreement.

Respiratory is a key strategic area for Nycomed, including the COPD treatment Daxas (roflumilast), Alvesco (ciclesonide) for asthma, and Omnaris (ciclesonide) for allergic rhinitis. The collaboration with Nycomed reinforces Orion’s presence throughout Europe and is in line with Orion’s strategy to strengthen its marketing position in Europe and the sales coverage through partnerships. The co-marketing area – in which both companies present their own product brands under the Easyhaler umbrella brand – covers the major European countries, including Austria, the Benelux countries, France, Germany, Greece, Italy, Poland, Portugal, Spain, and Switzerland. Orion will retain exclusive marketing rights for the Nordic countries, UK, and Eastern Europe, where the company is currently promoting single molecule Easyhaler products. Orion will exclusively manufacture the Easyhaler combination products covered by the agreement.

Orion’s portfolio of proprietary products includes Easyhaler, an in-house developed dry-powder inhaler. Orion has developed Easyhaler-adapted dry powder formulations of several well-known generic active substances (salbutamol, beclometasone, budesonide, formoterol) used in the treatment of asthma and COPD. At the moment, under development are new combined formulations of budesonide-formoterol, and fluticasone-salmeterol for the treatment of asthma and COPD.

Orion is an innovative European R&D-based pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets.

Nycomed is a privately owned global pharmaceutical company with a diversified portfolio focused on branded medicines in gastroenterology, respiratory, and inflammatory diseases, pain, osteoporosis, and tissue management. A range of OTC products completes the portfolio.

Bohai Pharmaceuticals Acquires Yantai Tianzheng Pharma for $35 Million

Bohai Pharmaceuticals Group, Inc. recently announced it has consummated a significant acquisition of a complementary Traditional Chinese Medicine (TCM) company in China, Yantai Tianzheng Pharmaceutical Co., Ltd. Like Bohai, Yantai Tianzheng produces, manufactures, and distributes modernized herbal medicines based on TCM in China.

Based in Yantai City (where Bohai is also located), Yantai Tianzheng achieved audited revenue of $37.9 million and net income of $6.3 million in its fiscal year ended December 31, 2010. For the 3 months ended March 31, 2011, Yantai Tianzheng achieved unaudited revenue of $11.3 million, an increase of 67% over the same period last year, and net income of $1.9 million, a 56% increase over the 3 months ended March 31, 2010. As of March 31, 2011, Yantai Tianzheng had working capital of $2.1 million and net tangible assets of $5.9 million. In terms of relative size, the acquisition represents a significant add-on to Bohai’s existing TCM business, which achieved unaudited net sales of $74.5 million and net income of $14 million for the trailing 12 months ended March 31, 2011.

Under the terms of a share purchase agreement, Bohai will acquire 100% of the outstanding shares of Yantai Tianzheng from its three shareholders for $35 million in an all cash transaction consisting of four installment payments over 18 months. Notwithstanding the installment payment structure, Bohai will obtain full ownership of Yantai Tianzheng immediately, with an effective transaction date of July 1, 2011. Mr. Jiangbo Chi, Yantai Tianzheng’s majority owner and CEO, will remain with Bohai to oversee the Yantai Tianzheng business. Bohai expects to fund this acquisition from cash on hand, future cash flow, and from third-party debt and/or equity sources. Additional details of the transaction will be available in Bohai’s Form 8-K to be filed with the Securities and Exchange Commission.

Yantai Tianzheng markets five primary products: Fangfengtongsheng Granule; Zhengxintai Capsule; Maitong Granule; Bezoar Antipyrotic Tablet; and Sanqi Shang Tablets. Yantai Tianzheng has annual production capacity of 400 million tablets, 300 million capsules, and 250 million bags of granules respectively, which adds to Bohai’s current capacity of 1,350 million tablets, 370 million capsules, and 30 million bags of granules and other product categories.

Bohai and Yantai Tianzheng have collaborated in the past. In 2008, Bohai granted Yantai Tianzheng a non-exclusive license to market and sell Yantai Tianzheng’s products under the Bohai brand and trademark for five years. No other relationship existed between the two companies prior to the acquisition.

Bohai Pharmaceuticals Group, Inc. is engaged in the production, manufacturing, and distribution of modernized herbal pharmaceuticals based on Traditional Chinese Medicine in China. Bohai’s medicines address common health problems, such as rheumatoid arthritis, viral infections, gynecological diseases, cardiovascular issues, and respiratory diseases.

FDA Tentatively Approves Intelliject’s Lead Product e-cue

Intelliject, Inc. recently announced the US FDA has granted tentative approval for the company’s NDA for a novel epinephrine auto-injector, e-cue, for emergency treatment of allergic reactions, including anaphylaxis.

The tentative approval of e-cue following a first cycle, 10-month review by the FDA provides validation of Intelliject’s vision of developing patient-centric products and of the company’s ability to execute.

“e-cue’s tentative approval is another important step along our journey to empower patients living with serious medical conditions,” said Spencer Williamson, President and CEO of Intelliject

Obtaining a tentative approval means that the product review is complete and the submission met the FDA’s requirements to be approved. The FDA reserves final approval of the product, however, until all exclusivity or patent challenges have been resolved, specifically the current patent litigation brought against Intelliject by King Pharmaceuticals, Inc. (King) and Meridian Medical Technologies, Inc. (Meridian). Final FDA approval is required before a product can be marketed in the United States.

Intelliject is confident that the pending patent disputes with King and Meridian will be favorably resolved and looks forward to obtaining final FDA approval and to e-cue’s subsequent availability.

Intelliject is a specialty pharmaceutical company dedicated to developing drug/device combination products that empower patients to gain freedom from their medical conditions. Each Intelliject product combines an established drug with an innovative delivery platform with the goal of achieving superiority, patient preference, and cost effectiveness.

Intelliject applies rigorous selection criteria to identify areas where its patient-centric approach and proprietary technology will offer superior solutions. The company only proceeds to an active development program once it has established that incremental clinical and economic benefit is achievable.