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Pfizer Provides Update on its Breast Cancer Candidate

Pfizer

Today, Pfizer Inc. announced that it is in discussion with the US Food and Drug Administration (FDA), regarding its potential blockbuster breast cancer drug palbociclib.

According to the company, it expects to get a final decision from the agency by April 13. Pfizer said that the FDA is not requiring a meeting of its Oncologic Drugs Advisory Committee to discuss Ibrance (palbociclib) prior to an approval decision.  Analysts have said that the agency's move to not require an advisory meeting may be good news for the company. Following the announcement, Pfizer’s shares rose two percent.

The company reported that it has entered label discussions with the FDA and hopes to bring the drug to patients who need it as soon as possible.

In April 2013, palbociclib received FDA breakthrough therapy designation and was accepted for filing and granted priority review from the agency in last October. The decision to grant the drug priority review is based in part on the final results of the Phase II PALOMA-1 trial, which includes patients with ER-positive, HER-2-negative advanced breast cancer. In the Phase II trial, treatment with palbociclib nearly doubled the median progression-free survival (PFS), with patients treated with palbociclib in combination with letrozole demonstrating a median PFS of 20.2 months compared to a median PFS of 10.2 months in patients receiving letrozole alone.

The drug is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation. Loss of cell cycle control is a hallmark of cancer and CDK 4/6 are overactivated in several cancers. The drug is seen as a key asset in Pfizer’s pipeline, which could generate $4 billion in sales in 2020, according to estimates from J.P. Morgan.

Source: Pfizer Inc.

Last updated: 1/8/15; 12:15pm EST

FDA Panel Recommends Approval of Sandoz's Biosimilar Version of Neupogen

Sandoz

A panel of advisors for the US Food and Drug Administration (FDA) has recommended approval of Novartis’ investigational biosimilar version of Amgen’s Neupogen (filgrastim).

The agency’s independent Oncologic Drugs Advisory Committee (ODAC) voted 14-0 in favor of approving Novartis’ biosimilar version of Amgen’s cancer drug Neupogen, which boosts white blood cell production. Although the FDA is not required to follow the recommendation made by the group, it often does.

The committee’s decision has paved the way for the introduction of the first ever biosimilar in the US market. It came two days after an FDA staff review determined that Novartis’ biosimilar should be approved for all the five indications Neupogen is currently approved for. The FDA is expected to make a final decision on its approval in the coming months.

Novartis’ generic arm Sandoz plans to launch the drug under the name Zarxio, which is currently marketed under the brand name Zarzio in more than 40 countries outside the US, generating nearly 7.5 million patient-exposure days of experience.

“We are pleased with the ODAC’s recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing,” said Mark McCamish, MD, PhD, Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the US.”

Amgen’s Neupogen generated an estimated $1.2 billion in sales in 2014. It is a part of the growing class of biologic medicines that are more complex and generally more expensive than chemical drugs. Biosimilars are not expected to reduce drug prices to the extent that chemical generics do. Novartis may charge the same price for Zarxio as Neupogen in some indications, but the cost to insurers and consumers will be lower.

Source: Sandoz

Last updated: 1/8/15; 9:50am EST

Janssen in Up to $700 Million Deal with MacroGenics for its Cancer Candidate

Janssen

Johnson & Johnson’s Janssen Biotech subsidiary has agreed to pay up to $700 million for MacroGenics’ blood cancer drug.

The companies have entered into a global collaboration and license agreement for MGD011, MacroGenics’ product candidate that incorporates its proprietary platform for Dual-Affinity Re-Targeting (DART) to simultaneously target CD19 and CD3 for the potential treatment of B-cell malignancies.

Under the agreement, Janssen will pay MacroGenics an upfront license fee of $50 million and will invest $75 million to purchase 1,923,077 new shares of MacroGenics common stock at a price of $39 per share. Janssen will be responsible for developing MGD011 following submission of the investigational new drug (IND) application, which is planned for 2015. If the drug is successfully developed and commercialized, MacroGenics could receive up to an additional $575 million in milestone payments. MacroGenics will have the option to fund a portion of late-stage clinical development, in order to receive a profit share in the US and Canada. If approved, the company could be eligible to receive double-digit royalties on any global net sales and has the option to co-promote the drug with Janssen in the US.

MGD011 is a humanized CD19 x CD3 bispecific DART protein, which is being developed for the treatment of B-cell hematological malignancies. CD19 is a lymphocyte-specific marker expressed from early B-lymphocyte development through mature memory B cells. It is highly represented in B-cell malignancies, making it an attractive target for interventions. MGD011 is designed to redirect T cells through their CD3 component to eliminate CD19-expressing cells found in many hematological malignancies. The drug has been designed to address half-life challenges posed by other programs targeting CD19 and CD3. According to the company, MGD011 and its DART molecules that redirect T cells against cancer targets are developed using a conventional antibody platform without the complexity of having to genetically modify T cells from individual patients as required by approaches, such as chimeric antigen receptor (CAR) T-cells.  

“MGD011 is a promising product candidate and one that we believe is meaningfully differentiated from competing CD19-directed therapies,” said Scott Koenig, MD, PhD, President and CEO of MacroGenics. “Janssen represents the ideal partner for this product candidate, given their track record of successfully developing and commercializing transformative oncology therapies and their experience in the B-cell malignancy area. We look forward to working with Janssen to significantly expand the development of MGD011 and maximize its value.”

Source: MacroGenics, Inc.

Last updated: 12/22/14; 12:10pm EST

FDA Grants Accelerated Approval to AstraZeneca's Lynparza

FDA

Today, AstraZeneca announced that the US Food and Drug Administration (FDA) granted an accelerated approval to its ovarian cancer treatment.

The company said that its Lynparza (olaparib) capsules has been approved by the agency as the first monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. The FDA’s approval comes just a day after the drug was approved by the European Commission.

In June, an FDA advisory panel voted against granting the drug an accelerated approval, due to olaparib’s failure to significantly improve overall survival (OS), some adverse events and doubts in the reliability of the drug’s progression-free survival (PFS). The group voted 11-2 against recommending an early approval for olaparib, but AstraZeneca provided additional information supporting the drug’s use in this patient population.

“Lynparza is an excellent example of how advances in the understanding of cancer biology can be used to develop the next generation of targeted medicines. It is a much-needed new therapeutic option for patients with germline BRCA-mutated advanced ovarian cancer. Today’s approval also marks the first of what we hope will be a number of indications in which this medicine has the potential to improve the lives of cancer patients,” said Dr. Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.

The drug’s approval was based on existing objective response rate and duration of response data. In a trial consisting of 137 patients, olaparib was associated with an overall response rate of 34 percent and the median response duration was 7.9 months. To date, the most common adverse events related treatment with olaparib monotherapy include nausea, vomiting, fatigue and anemia. To convert the accelerated approval to a full approval, a full review of data from either of two ongoing studies under the SOLO Phase III clinical program will be required.

“Ovarian cancer is diagnosed in nearly 22,000 women per year. The long-term survival rate in patients with advanced ovarian cancer is 10% to 30%. The FDA approval of Lynparza is a significant milestone for our patients as currently there are only limited treatment options available to women with ovarian cancer who carry the BRCA mutation,” said Dr. Ursula Matulonis, Associate Professor of Medicine, Harvard Medical School and Director of the Gynecological Oncology Program at the Dana-Farber Cancer Institute.

Earlier this year, AstraZeneca said that it expects olaparib to generate $2 billion in sales. The drug was approved alongside a companion diagnostic from Myriad Genetics that can determine which patients have the right genetic profile for the drug.

Source: AstraZeneca plc

Last updated: 12/19/14; 2:25pm EST

Gilead and Ono Enter into License Agreement for Ono's Cancer Drug

Gilead Sciences

Gilead Sciences is teaming up with Ono Pharmaceutical to expand its oncology business.

The companies announced that they have entered into an exclusive license agreement for the development and commercialization of ONO-4059, Ono’s oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases. Gilead will pay Ono an undisclosed upfront payment plus additional milestone payments. The two companies will collaborate on the development of the drug, currently in Phase I, and Gilead will have exclusive rights to develop and commercialize ONO-4059 in all countries of the world outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where Ono retains development and commercialization rights.

“We are pleased to partner with Gilead to accelerate worldwide development and commercialization of ONO-4059,” said Gyo Sagara, Ono’s President, Representative Director and Chief Executive Officer. “Our goal is to bring better therapeutic options as quickly as possible for the patients with B-cell malignancies or other diseases in the world, and we believe we can fulfill the goal by pursuing the development of Ono-4059 with Gilead.”

ONO-4059 is a selective, once-daily, oral BTK inhibitor, which has been shown to play a role in the survival and proliferation of malignant B-cells. Ono has presented preliminary Phase I data regarding the drug’s clinical activity in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) at multiple scientific conferences. The companies said that they intend to develop the drug for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with approved and investigational agents, including combinations with Gilead’s kinase inhibitors.

“With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies – PI3K delta, Syk, JAK and BTK,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead’s other kinase inhibitors with a goal of achieving more pronounced and more durable response rates. We look forward to working with Ono to move the ONO-4059 development program forward as quickly as possible.”

Source: Gilead Sciences

Last updated: 12/19/14; 1:25pm EST