Wiping its slate ahead of BMS buy, Celgene to pay 117M Dollars in Revlimid antitrust settlements

Fiercepharma | August 01, 2019

With Celgene making the big move under Bristol-Myers Squibbs umbrella, the drugmaker is looking to clear its books before the merger. Two antitrust settlements totaling more than 100 million dollars could help soothe BMS mind. Celgene will pay Mylan 62 million dollars to settle claims that it intentionally stifled generic competition for its blockbuster multiple myeloma med Revlimid and predecessor Thalomid. The Big Biotech refused to sell samples of the two drugs to generics makers, the lawsuit said—and those samples are necessary for copycats to win FDA approval. Without the samples, Mylan couldn't perform the bioequivalence testing necessary to formulate a generic and submit it to the FDA for approval. Mylan’s suit, filed in 2014, was scheduled for trial in October, according to an SEC filing. Celgene chose not to comment on the settlement. The Mylan settlement follows a separate $55 million payout to close a class-action lawsuit from the International Union of Bricklayers and Allied Craft Workers Local 1 Health Fund. In that case, the union claimed Celgene not only refused to sell Revlimid and Thalomid samples, but also filed superfluous patent challenges to protect its drugs and agreed to exclusive supply agreements to stem the flow of Thalomid’s active ingredient from other suppliers. Celgene approved that settlement a week ago.

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BUSINESS INSIGHTS, PHARMACY MARKET

DirectRx Announces Rebranding Specialty Pharmacy Services

DirectRx Pharmacy | February 15, 2023

On February 14, 2023, DirectRx, a leading national specialty pharmacy committed to serving individual patients with chronic and complex health needs, announced the launch of a new website and a suite of team member training programs. The new website emphasizes the company's dedication to working with patients and prescribers to provide the best possible care. The training programs are designed to assist team members in developing professionally. The DirectRx website emphasizes the company's concern for patients and dedication to collaborating with doctors to offer the highest quality care. The new additions to the website consist of a Prescribers tab highlighting the key ways in which DirectRx collaborates with its prescriber partners; a manufacturers tab highlighting the company's "industry best" time-to-fill, adherence and conversion rates; and an interactive Careers tab to help grow the DirectRx team. Additionally, DirectRx has launched new training and development programs for team members to help them improve their skill set and stay with the firm longer. The new programs include pharmacy technicians in training, account managers in training and regional patient care coordinators in training. The specialty pharmacy is also expanding its managerial positions, including a customer service manager role and others. DirectRx's Director, Alban Ivezaj, commented, "We're very excited to launch our new website as we feel it better captures our commitment to compassionate patient care and the best-in-class services we offer to our provider partners." He added, "As a result of that commitment, DirectRx has experienced significant growth across all regions of the U.S. - including servicing all 50 states and a 26 percent increase in the number of patients we serviced in 2022." (Source – Globe Newswire) About DirectRx Pharmacy Founded in 1985, DirectRx is an independent pharmacy committed to providing patients with exceptional, individualized pharmaceutical care. With the belief that communication and teamwork are crucial to achieving good treatment outcomes, the physician, patient, and pharmacist form a circle of integrated services and coordinated care, so there are no gaps in patient care between physician and pharmacist. It stands apart from the competition due to its concern and commitment to providing unmatched customer service. The company is accredited by ACHC, NABP, WBENC and URAC. Since its establishment over three decades ago, the company has expanded to 49 states.

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PHARMA TECH

USFDA Accepts BioMarin's sNDA to Expand Use of VOXZOGO

BioMarin Pharmaceutical Inc. | March 08, 2023

On March 7, 2023, BioMarin Pharmaceutical Inc., a global biotech company focused on improving lives via genetic discovery, announced that the US FDA has accepted its supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand the treatment of achondroplasia in children under the age of 5. Achondroplasia is a common form of disproportionate short stature. The FDA has set an action date of October 21, 2023, for the sNDA. The sNDA is supported by data from a Phase 2 double-blind, randomized, placebo-controlled clinical trial, which showed similar safety and efficacy profiles in children under five years of age compared to those aged five years and older. The European Medicines Agency (EMA) also validated BioMarin's application for VOXZOGO in January to treat children under the age of 2. If approved, VOXZOGO could be prescribed for over 1,000 additional children from birth for achondroplasia. VOXZOGO is the first EMA and FDA-approved treatment for achondroplasia with open bone growth plates. The treatment uses a new class of therapy, C-type natriuretic peptide (CNP) analog, which promotes bone growth by acting as a positive regulator of the signaling pathway downstream of the fibroblast growth factor receptor 3 gene (FGFR3). The drug is approved in the EU, Brazil, and Australia for children aged two years and above with epiphyses (bone growth plates) and in Japan for children from birth who have achondroplasia with open growth plates. BioMarin has enrolled 250 children with achondroplasia in seven clinical studies in eight countries to evaluate the safety and efficacy of VOXZOGO. About BioMarin Pharmaceutical Inc. BioMarin is a leading biotechnology firm established in 1997 with a mission to transform people's lives by using genetic discovery. The company creates targeted therapies that address the underlying cause of genetic disorders to improve the quality of life for individuals with rare genetic diseases. It has developed eight first or best-in-class treatments and has a range of product candidates to address various genetic disorders using the same science-based approach. As BioMarin continues to create new and innovative solutions, it has the potential to impact the lives of even more people. The company is committed to prioritizing patients and their needs in its approach to drug development.

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BUSINESS INSIGHTS, PHARMACY MARKET

Accord Healthcare Expands Offerings with Generic Relapsing MS Drug

Accord Healthcare | March 14, 2023

On March 13, 2023, Accord Healthcare informed that it has expanded its portfolio with Teriflunomide, a film-coated tablet equivalent to Sanofi Genzyme's Aubagio. The drug treats relapsing forms of MS in adults, including clinically-isolated syndrome and active secondary progressive disease. The company offers Teriflunomide in 14 mg and 7 mg tablets, now available for shipping. Teriflunomide has been granted FDA approval as an immunomodulatory agent for patients aged 18 and above. Its purpose is to reduce the frequency and severity of relapses, which can lead to new or worsening neurological symptoms associated with the disease. Accord Healthcare US Vice President of Sales Jim Brown stated, "We're proud to add Teriflunomide to our portfolio. This is an important oral therapy for the millions of patients living with relapsing MS." He added, "Generic medicine allows broad access to effective therapy, to help improve disease course and potentially slow progression of MS." (Source – Cision PR newswire) Teriflunomide is an immunomodulatory medication that inhibits an enzyme critical to a metabolic pathway that supports lymphocyte proliferation. This results in fewer activated lymphocytes, which minimizes inflammation and immunological reactivity, resulting in lower recurrence rates and protection of brain volume against inflammatory nerve cell attacks. Around 2.8 million people globally have multiple sclerosis, with the majority diagnosed with relapsing-remitting MS that typically begins in their twenties or thirties. Diagnosis involves experiencing two or more attacks or relapses while maintaining stability. New or exacerbated symptoms characterize relapses, and the immune system attacks the myelin sheath surrounding nerve fibers, ultimately causing long-term damage. Symptoms include numbness, fatigue, double vision, and balance problems. Besides, relapsing-remitting MS can also progress to active secondary progressive disease. About Accord Healthcare Accord Healthcare, a subsidiary of Intas Pharmaceuticals, is recognized as a prominent player in the generic pharmaceutical industry. The company's vision is to enhance patient access to medicines and revolutionize the pharmaceutical experience for healthcare providers and patients. With an emphasis on advanced manufacturing technology and in-house research, Accord Healthcare delivers a wide range of affordable, complex, and essential medicines. The company's dedication to forward-thinking and innovative solutions remains at the core of its mission. Headquartered in Durham (North Carolina), its products are marketed in 80 countries through the Intas network.

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