PFIZER TO PRESENT NEW DATA ON INVESTIGATIONAL TOFACITINIB AT THE 11TH CONGRESS OF ECCO

Pfizer Inc announced today that seven abstracts reporting on new research for tofacitinib in ulcerative colitis (UC) and Crohn’s disease will be presented at the 11th Congress of ECCO, which will be held March 16-19 in Amsterdam, The Netherlands. Among the abstracts are detailed results from two pivotal Phase 3 studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) program. Tofacitinib is being studied as an investigational treatment for adult patients with moderate to severe active UC.

The full list of abstracts to be presented at the 11th Congress of ECCO follows:

Ulcerative Colitis

1. Efficacy and safety of oral tofacitinib as induction therapy in patients with moderate to severe ulcerative colitis: results from two phase 3 randomized controlled trials (OP019, Friday, March 18, 15:40 - 15:50)

2. Improvement in patient-reported outcomes in two phase 3 studies of tofacitinib in patients with moderately to severely active ulcerative colitis (P369, Friday, March 18, 12:20 - 13:20)

3. Tofacitinib plasma concentration monitoring is not needed for optimization of induction therapy in moderate to severe ulcerative colitis: results of pooled exposure-response analyses of phase 3 induction studies (DOP071, Friday, March 18, 18:54 - 19:01)

Crohn’s Disease

4. Efficacy and safety of oral tofacitinib for maintenance therapy in patients with moderate to severe Crohn’s disease: results of a phase 2b randomized placebo-controlled trial (OP021, Friday, March 18, 17:10 - 17:20)

5. Efficacy and safety of oral tofacitinib for induction therapy in patients with moderate to severe Crohn’s disease: results of a phase 2b randomized placebo-controlled trial (OP022, Friday, March 18, 17:20 - 17:30)

6. Effects of oral tofacitinib on patient-reported outcomes in patients with moderate to severe Crohn’s disease: results of two phase 2b randomized placebo-controlled trials (DOP053, Friday, March 18, 18:54 - 19:01)

7. Tofacitinib pharmacokinetics and durability of drug exposure in moderate to severe Crohn’s disease patients in phase 2 induction and maintenance studies (P428, Friday, March 18, 12:20 - 13:20)

Pfizer Enters into Collaboration with Adaptive Biotechnologies

Pfizer Inc and Adaptive Biotechnologies Corporation have entered into a translational research collaboration to leverage next generation sequencing of the adaptive immune system to advance Pfizer’s growing immuno-oncology franchise. Under the terms of the agreement, Pfizer and Adaptive will seek to combine drug development and platform technology biomarker expertise to identify patients who may preferentially benefit from immunotherapy.

 

Understanding and reliably measuring each patient’s immune response to their cancer before and after therapy is critical to defining the most appropriate immunotherapy for that patient. Adaptive’s immunosequencing platform quantitatively and reproducibly measures the patient’s immune-cell repertoire, providing a powerful translational tool to accelerate Pfizer’s immuno-oncology biomarker and drug development programs.

Adaptive Biotechnologies, the leading experts in profiling the immune cell repertoire, will work with Pfizer to apply their proprietary immunosequencing platform technology, bioinformatics capability, and scientific expertise to advance Pfizer’s rapidly expanding immuno-oncology pipeline.

Merck KGaA and Pfizer Initiate Two Phase III Studies of Investigational Immunotherapy Avelumab

Merck KGaA, Darmstadt and Pfizer announced the initiation of two Phase III studies of avelumab*, an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody, in treating advanced or metastatic gastric/gastro-esophageal junction (GEJ) cancers, which are aggressive cancers with poor survival rates. These pivotal trials are investigating avelumab in the first-line and third-line settings, with overall survival (OS) as the primary endpoint in both trials.

JAVELIN Gastric 100, a study comparing the switch from first-line chemotherapy to maintenance therapy with avelumab versus continuation of chemotherapy, is a multicenter, international, randomized, open-label Phase III trial designed to evaluate the potential superiority (based on OS) of maintenance therapy with avelumab in patients with unresectable, locally advanced or metastatic gastric/GEJ cancers whose disease has not progressed with first-line platinum-based chemotherapy. This is currently the only Phase III trial in gastric cancer that is designed to evaluate superiority of an immunotherapy compared with conventional platinum-based chemotherapy as a first-line maintenance treatment. The study will enroll 629 patients across more than 220 sites in Asia Pacific, Europe, North America and South America.

The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/GEJ cancers, head and neck cancer, Merkel cell carcinoma, melanoma, mesothelioma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer. Clinical trials for both of the gastric/GEJ Phase III trials in North America will be conducted on behalf of Merck KGaA, Darmstadt, Germany, by EMD Serono, the company’s US and Canadian biopharma business.

Pfizer to Present New Data on Eliquis

Bristol Myers Squibb and Pfizer announced that 22 abstracts will be presented at the American Heart Association (AHA) Scientific Sessions 2015, to be held November 7-11 in Orlando, Florida. The new data, including four oral presentations, contribute to the Bristol-Myers Squibb and Pfizer Alliance’s research in nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE) in patients treated with Eliquis. Abstracts include new data analyses from the pivotal Phase 3 study, ARISTOTLE, as well as a number of real-world data analyses.

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquisdecreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from seven Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.

Global Analysis Of Metastatic Breast Cancer

Pfizer Inc., working collaboratively with the European School of Oncology (ESO), within the scope of the Advanced Breast Cancer Third International Consensus Conference (ABC3), released the Global Status of Metastatic Breast Cancer (MBC): A 2005 – 2015 Decade Report, which revealed both areas of improvement and substantial gaps in care, access to resources and support, and treatment outcomes for women with MBC.

MBC is the most advanced stage of breast cancer for which there is no cure. Further, public health experts estimate there will be a 43 percent increase in breast cancer related deaths globally from 2015 to 2030, the majority of which are a result of metastatic disease. Previous research has shown that women with MBC have distinct needs that are not often addressed and there are fewer patient and community resources available for these women compared with those for women with early-stage disease.

Over the past decade - due to the collective efforts of the broader breast cancer community - some progress has been made to address the unique needs of women with MBC. However, there is still a great deal of improvement that needs to be made in this area. The findings from theGlobal Status of MBC: A Decade Report reinforce the urgent need for change in MBC care, patient support, research and the important role increased disease awareness can play.

Primary Survey Highlights

Three new studies evaluating the current state of breast cancer from the perspective of breast cancer care centers, patient support organizations and the general population found:

• More than half of 582 surveyed oncologists and other healthcare practitioners in the U.S., Europe, Latin America and Australia, report that they have not been trained on how to effectively deliver difficult information to their patients and have a desire for more training.
• The majority of the 50 interviewed patient support organizations in North America, Europe, Asia Pacific, Latin America, Africa and the Middle East, recognize women with MBC require more support than those with early-stage disease, but report a range of barriers that can impact efforts to meet patient needs, including limited resources, cultural views and logistics.
• There is a global lack of familiarity with metastatic or advanced breast cancer among the general public leading to widespread misperceptions about the disease, according to a survey of more than 14,000 people in 14 countries throughout Europe, Latin America, the Middle East, Africa and the Asia Pacific.
  • The survey also found that among the general public, approximately 1 out of 5 people believe that those with metastatic breast cancer should keep their diagnosis a secret and not discuss their disease with anyone other than their physician, potentially contributing to the stigma that is associated with MBC and leading to feelings of isolation by the patient.

These findings reinforce results from a 2014 survey conducted by Pfizer and breast cancer leaders in the United States that found the majority of Americans (60%) know little to nothing about MBC.

Secondary Analysis Highlights

An analysis of more than 3,000 previously published articles and abstracts identified key limitations to progress for women with MBC over the past decade relating to patient care, the environmental landscape and scientific research, including:

• Despite the benefits of supportive and palliative care to the quality of life for patients, implementation of supportive care has been variable across certain countries and significant gaps remain.
• Better psychological support for women with MBC is needed to ease the end-of-life care experience, particularly when it comes to anxieties about what they may experience.
• There has not been a significant improvement in the quality of life for women with MBC in more than a decade, and there has even been a slight decrease since 2004.
• The pace of innovation in MBC appears to have slowed in recent years with treatment advances, clinical research, publications and guideline development, particularly when compared with other tumor types, such as melanoma and lung cancer.

Pfizer Expands its Patient Assistance Program

In response to the ongoing challenges patients face in paying their out-of-pocket costs for their prescription medicines, Pfizer announced that it will immediately double the allowable income level for its patient assistance program, so that even more patients in need could be eligible to receive their Pfizer medicines for free. With this change, more than 40 medicines offered for free through the program will now be available to eligible patients earning up to 4 times the Federal Poverty Level (FPL) adjusted for family size ($47,080 for a single person; $97,000 for a family of four).

Through its Pfizer RxPathways program, Pfizer offers patients, including those with health insurance and those without, a range of individual services to help them gain access to Pfizer medicines. In the last five years alone (2010-2014), Pfizer has helped nearly 2.5 million uninsured and underinsured patients get access to more than 30 million Pfizer prescriptions, making it the most comprehensive program of its kind.

Pfizer RxPathways is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™.

Pfizer RxPathways is part of Pfizer’s corporate social investment strategy that focuses on leveraging the full range of the company’s resources – people, skills, expertise and funding – to broaden access to medicines and strengthen health care delivery for underserved people around the world.

New Data on the Safety and Efficacy of XELJANZ

Pfizer Inc. announced that 26 new scientific abstracts, including 20 presentations for XELJANZ® (tofacitinib citrate) in rheumatoid arthritis (RA) will be presented on behalf of Pfizer at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) 2015 Annual Meeting.

XELJANZ (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) Inhibitor. XELJANZ is the first and only JAK inhibitor approved in over 40 countries around the world for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs). The benefit:risk profile of XELJANZ in RA has been studied in approximately 6,200 patients with more than 19,000 patient-years of drug exposure in the global clinical development program for XELJANZ in moderate to severe RA. A new drug application (NDA) for XELJANZ 11 mg once-daily modified release for the treatment of moderate to severe RA is under review with the U.S. Food & Drug Administration (FDA). In the United States, XELJANZ has a boxed warning for serious infections and malignancies.

Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program in a range of immune-mediated inflammatory conditions.

Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including stiffness and swelling in the joints, particularly those in the hands, feet and knees. Although the exact cause of RA is unknown, it is considered to be an autoimmune disease, because the immune system in people with RA mistakes the body’s healthy tissues as a threat and attacks them. Some people are at increased risk of developing RA, including people with a family history of RA, smokers and women. Three times as many women are affected by RA compared to men. RA affects an estimated 17.5 million people worldwide. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.

Pfizer Completes Acquisition Of Nimenrix And Mencevax

Pfizer Inc. announced that it has completed the acquisition of GlaxoSmithKline’s quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax. 

 

Nimenrix (meningococcal serogroups A, C, W-135 and Y conjugate vaccine) is a single-dose meningococcal ACWY-TT (tetanus toxoid) conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. It is indicated for all age groups above one year of age. Launched three years ago, Nimenrix is currently registered and approved for sale in 63 countries across the European Economic Area (EEA 30), Canada, Australia and Emerging Markets, with registrations under review in another 17 countries across Africa, Asia, Eastern Europe and the Middle East.

Mencevax (meningococcal polysaccharide serogroups A, C, Y and W-135 vaccine) is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers in countries where the disease is endemic or highly epidemic. Mencevax is indicated for use across all age groups from 2 years of age, and is currently registered and approved in 78 countries across Africa, Asia, Australia, Europe, Latin America, Middle East and New Zealand.

Sayana Press Becomes First Injectable Contraceptive in UK

Pfizer Inc. announced that the company’s injectable contraceptive, Sayana®Press (medroxyprogesterone acetate), is now available to women in the United Kingdom (UK) for administration by self-injection. This follows the recent approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of an update to the Sayana® Press label, adding the option for self-injection by women when considered appropriate by a healthcare professional (HCP).

Sayana® Press is the first injectable contraceptive in the UK available for administration via self-injection. This new method of administration is also approved or pending local approval in additional European Union (EU) markets (Austria, Belgium, Hungary, Ireland, Netherlands). Pfizer will continue its efforts to help bring this updated label to more countries across the globe, with an initial focus on those in the developing world – such as in Burkina Faso, Senegal and Uganda – where data show unmet need  and demand for injectable contraceptivesiv. Sayana® Press is not yet approved for self- injection outside of the EU.

Sayana® Press combines a long-acting, reversible, contraceptive with an all-in-one prefilled, single-use, non-reusable Uniject™ injection system, eliminating the need to prepare a needle and syringe. Approved for use by the MHRA in 2011, the contraceptive is indicated for the prevention of pregnancy. Each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- one week). 

Merck KGaA and Pfizer to Present Updates for Avelumab at the European Cancer Congress 2015

Merck KGaA, Darmstadt, Germany and Pfizer announced that six abstracts on studies evaluating the potential role of programmed death-ligand 1 (PD-L1) inhibition and the safety and efficacy of the investigational cancer immunotherapy avelumab* will be presented at this year’s ECC in Vienna, Austria, September 25–29, 2015.

New data will be presented in urothelial (e.g. bladder), mesothelioma and gastric/gastroesophageal cancers. Additional NSCLC and ovarian cancer data from Phase Ib trials build on those previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO). As the promise of immuno-oncology continues to grow, these new data help to further the understanding of the potential role of avelumab for patients suffering from cancers with high unmet need.

Despite continued progress in bringing new treatments to patients, there remains a significant unmet need across many types of cancer. For example, the incidence of gastric cancer remains a major public issue in Western and Asian countries, and there is a continued need to better understand the disease biology to provide patients with the most appropriate and effective treatment. For some cancer types, such as mesothelioma, the incidence rates are rising worldwide, with limited treatment options currently available for patients.

Currently, more than 1,000 cancer patients have been treated with avelumab in the Phase I/Ib clinical program (JAVELIN Solid Tumor), and more than 15 tumor types are under investigation.

India rejects patent on Pfizer's arthritis drug

India has again denied Pfizer Inc a patent on its rheumatoid arthritis drug tofacitinib, the latest setback for a multinational drugmaker seeking to enforce its intellectual property rights in the country. Pfizer sought a patent that covers an important chemical formulation of the active compound in the medicine, but the Indian Patent Office said the company would have to establish that the compound for which it is seeking a patent is therapeutically more effective than the active compound.

"The invention disclosed and claimed in the instant application ... is not considered as an invention under the provisions of the Act," Bharat N S, an assistant controller at the patent office, wrote in an order dated Sept. 3. Pfizer is reviewing its options for further action, a Mumbai-based company spokesman said in an emailed statement. 

Drug patents have become a thorny issue for global drugmakers seeking to expand in India's fast-growing healthcare market. Companies including Pfizer, Bayer and Roche have in recent years struggled to retain exclusivity on drugs in India, and have blamed patent laws they say are designed to favor the local industry.

India, however, has said its drug patents policy is designed to ensure medicines remain affordable for the country where less than 15 percent of the population has health insurance.

India's patent office had rejected Pfizer's application to patent tofacitinib in 2011, but was ordered to reconsider the decision by the Intellectual Property Appellate Board, after Pfizer appealed.