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The SFJ Pharmaceuticals Group announces agreement with Pfizer to co-develop Dacomitnib as first-line treatment for patients with advances non-small cell cancer

On September 7, 2012 the SFJ Pharmaceuticals Group entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase III clinical trial of Pfizer’s investigational pan-HER inhibitor, dacomitinib (PF-00299804) (Press release SFJ Pharmaceuticals, SEP 7, 2012, View Source [SID:1234500284]). The trial, which will be conducted across multiple sites in Asia and Europe, will evaluate dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR).
Under the terms of the agreement, SFJ will provide the funding and clinical development supervision to generate the clinical data necessary to support a registration dossier on dacomitinib for marketing authorization by regulatory authorities for the indication: First-line treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations. If approved for this indication, SFJ will be eligible to receive milestone payments and earn-out payments.
This is the second collaborative agreement between SFJ and Pfizer. SFJ previously entered into an agreement with Pfizer to conduct a Phase 3 trial in Asia of Pfizer’s Inlyta (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.

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CRT, Astex Pharmaceuticals and The ICR announce Epigenetic Drug Discovery Collaboration

On September 7, 2012 CRT, Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics and The Institute of Cancer Research, London, reported they have initiated a collaboration to discover and develop drug candidates targeting an undisclosed epigenetic target in a blood cancer with high unmet medical need (Press release, Cancer Research Technology, SEP 7, 2012, View Source [SID1234523270]).

The collaboration combines Astex’s world-renowned fragment-based drug discovery platform and epigenetic* drug development experience with the expertise in blood cancer biology at The Institute of Cancer Research (ICR) and proven success in drug discovery at the Cancer Research UK Cancer Therapeutics Unit at the ICR.

Dysregulated epigenetic mechanisms are now understood to underlie a variety of cancer types, and have been successfully targeted by the first generation of epigenetic anticancer drugs**. In some cases, specific epigenetic mutational events can be linked to disease etiology, providing an opportunity to develop highly targeted personalised medicines and associated companion diagnostics that will ultimately improve survival and reduce side effects.

"We are delighted to be entering into this new collaboration with the ICR and CRT on a key epigenetics target," said Harren Jhoti, PhD, president of Astex Pharmaceuticals. "This new partnership builds on the highly successful collaboration which Astex entered into with the ICR and CRT in 2003 on another cancer target, PKB/Akt. That collaboration led to the discovery of two clinical candidates, the first of which, AZD5363, was taken into Phase I by our partner AstraZeneca in early 2011 and the second of which, AT13148, is being prepared to be taken into Phase 1 under our development partnership with Cancer Research UK. "

Professor Paul Workman, director of the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research, said: "ICR scientists are pioneers at unravelling blood cancer drug targets, which others have considered challenging to drug effectively. We have a very strong track record of designing drugs to attack challenging biological targets and bringing them into clinical trial, and given Astex’s complementary expertise, we are very excited about the potential of this collaboration."

Dr Phil L’Huillier, director of business management at CRT, said: "Putting in place this collaboration between the Cancer Research UK-funded drug discovery team at the ICR and Astex provides a powerful route to identify drug candidates for this promising new target.

"The deal will ensure that the research programme benefits from the necessary investment to progress the research to its full potential while building on the validation and assay development work that has been carried out at the ICR and funded by Cancer Research UK and others.

"We hope that this research will lead to the development of new drugs to ultimately improve survival for cancer patients."

ImmuNext Enters into a Strategic Partnership with Janssen, a subsidiary of Johnson and Johnson, to Develop Novel Immunotherapies for the Treatment of Cancer

On September 5, 2012 ImmuNext reported that it has entered into an agreement with Janssen Biotech, Inc., focused on the development of novel therapeutics that modulate the immune system for the treatment of cancer (Press release ImmuNext, SEP 5, 2012, http://immunext.com/news.php [SID:1234500867]).

Under the terms of the agreement, ImmuNext will grant Janssen a worldwide, exclusive license to develop and commercialize therapeutics that antagonize the V-region immunoglobulin-containing suppressor of T-cell activation (VISTA) signaling pathway. VISTA is a newly identified negative checkpoint regulator.

Potential payments to ImmuNext under the agreement include an upfront payment, plus payments for reaching certain development and commercial-based milestones, which could total more than $150 million. ImmuNext is also eligible to receive royalties on sales of products and sponsored research support.

ImmuNext and Janssen will engage in a collaborative effort to carry out research and development of cancer therapeutics that antagonize the VISTA signaling pathway. Janssen will be responsible for clinical development and commercialization of all products under the agreement.

"VISTA is an exciting, novel, negative checkpoint regulator that we anticipate will be a key target for enhancing immunity to solid and liquid cancers," stated Randolph Noelle, Ph.D, ImmuNext’s chief scientific officer.

"We look forward to working with Janssen, a global leader in the field of oncology, to develop innovative immunotherapies to improve the lives of cancer patients," commented David DeLucia, ImmuNext’s chief executive officer.

The ImmuNext technology is based on discoveries made in Dr. Noelle’s labs at the Geisel School of Medicine at Dartmouth and King’s College, London.

ImmuNext was represented by transaction counsel Charles Hoyng, PhD, of Latham Watkins, intellectual property counsel Robin Teskin of Hunton Williams, business development consultant, Chris Krueger and corporate counsel MaryLiz Geffert of McLane, Graf, Raulerson & Middleton.

Valeant Pharmaceuticals International, Inc. Agrees To Acquire Medicis Pharmaceutical Corporation For $44.00 Per Share In Cash

On September 3, 2012 Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) and Medicis Pharmaceutical Corporation (NYSE: MRX) reported that they have entered into a definitive agreement under which Valeant will acquire all of the outstanding common stock of Medicis for $44.00 per share in cash (Press release, Valeant, SEP 3, 2012, http://ir.valeant.com/news-releases/2012/03-09-2012 [SID:1234514633]). The transaction, which values Medicis’ common stock at approximately $2.6 billion, was unanimously approved by the Boards of Directors of both companies. The $44.00 per share price represents a 39% premium to Medicis’ closing share price on Friday, August 31, 2012, the last trading day prior to announcement, and a 31% premium to the three-month average trading price. The transaction is expected to close in the first half of 2013.

Medicis’ portfolio includes leading prescription brands SOLODYN, RESTYLANE, PERLANE, ZIANA, DYSPORT and ZYCLARA. The pro forma net revenue for the combined company’s dermatology and aesthetics businesses for 2012 is expected to exceed $1.7 billion within the United States.

Valeant’s Chairman and Chief Executive Officer, J. Michael Pearson , said, "The acquisition of Medicis represents a significant next step in our journey to become the leader in dermatology by strengthening Valeant’s presence in acne, actinic keratosis, aesthetic injectables and anti-virals, among others. Medicis’ highly complementary portfolio of leading branded products and promising pipeline is a solid strategic fit, and we look forward to leveraging Medicis’ well known and respected name in dermatology to drive long-term growth."

Jonah Shacknai , Chairman and Chief Executive Officer of Medicis, said, "Our Board of Directors believes this compelling all-cash transaction demonstrates the value our employees have created and the strength of our brand in the specialty pharmaceutical market. We look forward to combining our portfolio of products with Valeant, and we are confident that the combined portfolio under the Medicis name will be well positioned to capitalize on meaningful opportunities in the growing dermatology and aesthetics markets."

The transaction is subject to customary closing conditions, including approval by Medicis stockholders and expiration of any applicable regulatory waiting period. Valeant expects the transaction, once completed, to be immediately accretive to Valeant’s cash earnings per share. The combination is expected to yield cost synergies at an annual run rate of at least $225 million within six months of closing. Valeant has secured committed financing for 100% of the transaction value from J.P. Morgan Chase Bank, N.A.
The combined company’s commercial dermatology operations will be located in Scottsdale, Arizona and will operate under the name Medicis, a division of Valeant, with its dermatology research and development operations in Laval, QC, Scottsdale, AZ and Petaluma, CA, and corporate support functions primarily based in New Jersey.

J.P. Morgan Securities LLC acted as exclusive financial advisor to Valeant. Deutsche Bank Securities Inc. and Roberts Mitani, LLC served as financial advisors to Medicis. Sullivan & Cromwell LLP and Skadden, Arps, Meagher & Flom LLP served as Valeant’s legal counsel, and Medicis was advised by Weil, Gotshal & Manges LLP and Latham & Watkins LLP.

Teva Announces FDA Grants Approval for Tbo-filgrastim for the Treatment of Chemotherapy-Induced Neutropenia

On August 30, 2012 Teva reported that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years (Press release Teva, AUG 30, 2012, View Source [SID:1234500814]). Tbo-filgrastim is a short-acting recombinant form of G-CSF, indicated to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections.

Teva currently markets filgrastim in Europe under the trade name Tevagrastim, a biosimilar to Neupogen. Tbo-filgrastim was filed in the U.S. as a Biologics License Application (BLA) since a biosimilar approval pathway had not been established at the time of submission. Teva will market tbo-filgrastim as early as November 2013, in accordance with the settlement reached with Amgen.

"As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. "The approval of tbo-filgrastim demonstrates Teva’s strong commitment to providing patients with new treatment options. It expands upon Teva’s existing Oncology portfolio with the addition of the first biologic and supportive care agent for oncology patients."

In studies of tbo-filgrastim, the drug was shown to have statistically significant reductions in the duration of severe neutropenia compared to placebo. During the first 21-day chemotherapy cycle, patients treated with tbo-filgrastim had severe neutropenia for an average of 1.1 days, compared with 3.8 days for those receiving placebo.