Pharmaceutical Technology Editors

Recro Pharma announced on March 21, 2022 that it changed its name to Societal CDMO. The name change reflects the expansion and transformation of the company as a result of the acquisition and integration of IriSys, a contract development and manufacturing organization (CDMO) focused on product development and good manufacturing practice (GMP) manufacturing.

Societal CDMO focuses on solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development. The addition of IriSys in August 2021 expanded the company’s physical footprint to include facilities on both US coasts, diversification of its customer base, more service offerings, and enhancement of its industry expertise. The services of the company will now encompass therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, and packaging and logistic services to the global pharmaceutical market.

“When we set out to rebrand Recro, we sought a name and identity that carried with it a purpose, one which exemplified the commitment our employees demonstrate every day to making a positive impact within communities across the country and around the world,” said David Enloe, CEO of Societal CDMO, in the press release. “At the same time, we were also focused on effectively communicating our evolution as a partner to our clients, as well as our people, both today and in the future. We believe the name Societal CDMO, along with our new tagline of ‘Bringing Science to Society,’ captures not only where we find ourselves as a company today, but it reflects our inspiration for future growth as an organization.”

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Recro Pharma changed its name to Societal CDMO to reflect the company’s expansion as a result of the acquisition of IriSys.

Recro Announces Name Change to Societal CDMO to Reflect Corporate Expansion and Transformation

Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. and its affiliates, has reached an agreement with the Attorney General of Rhode Island that settles the state’s and its subdivisions opioid-related claims.

The settlement includes an ample supply of life-saving medicines to meet or exceed the current need in the state of Rhode Island for the next 10 years, including additional expenses from a previous trial that was set to start on March 16, 2022. Under the terms of the settlement, $21 million will be paid to Rhode Island by Teva over 13 years, and a combined value of $78.5 million (wholesale acquisition cost) of the generic of the company’s medicine Narcan (naloxone hydrochloride nasal spray) and buprenorphine naloxone (sublingual tablets) will be provided over 10 years.

Buprenorphine naloxone is the primary drug used to treat opioid addiction. Naloxone is a life-saving medication that can reverse an overdose from opioids.

According to a press release, “Teva believes that today’s settlement with the state of Rhode Island is in the best interest of those impacted by the opioid crisis and a critical step forward in getting life-saving treatments to the people who need them. This settlement agreement is not an admission of any liability or wrongdoing and the Company will continue to defend itself in court, in states where we have not reached terms of a settlement agreement.”

Teva has reached an agreement with the Attorney General of Rhode Island to settle opioid-related claims.

Teva Reaches Agreement with Rhode Island to Settle Opioid-Related Claims

AbbVie announced on March 16, 2022 that its treatment for moderately to severely active ulcerative colitis RINVOQ (upadacitinib) has been granted approval by FDA. The treatment if meant for adults who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers.

Ulcerative colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease that causes mucosal inflammation. Common symptoms and signs of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, and fecal incontinence. The disease is unpredictable and variable among patients.

"There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome," said Thomas Hudson, MD, senior vice-president of research and development and chief scientific officer of AbbVie. "With the approval of RINVOQ as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis."

"Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult," said Maria T. Abreu, MD, professor of medicine and professor of microbiology and Immunology at the University of Miami Miller School of Medicine and director of Crohn's & Colitis Center, University of Miami Health System. "In clinical trials, RINVOQ showed its ability to rapidly control symptoms in just eight weeks for many patients and sustained responses at one year. I believe these types of improvements can make a positive difference for my patients."

FDA has approved RINVOQ as a treatment for adults with moderately to severely active ulcerative colitis who have not had an adequate response to existing treatments. 

RINVOQ Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

On March 18, 2022, FDA approved Bristol-Myers Squibb Company’s Opdualag (nivolumab and relatlimab-rmbw) for use in adults and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The drug is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.

The efficacy of Opdualag was evaluated in a double-blinded trial in 714 patients with previously untreated metastatic or unresectable Stage III or IV melanoma. Patients were randomized to receive 480 mg of nivolumab and 160 mg of relatlimab by intravenous infusion every four weeks or 480 mg of nivolumab by intravenous infusion every four weeks until disease progression or unacceptable toxicity.

FDA granted priority review, fast track designation, and orphan drug designation to Opdualag due to its status as a treatment for a rare disease. The review used FDA’s Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment, according to the press release.

FDA has approved Opdualag for adults and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

FDA Approves Opdualag for Unresectable or Metastatic Melanoma

Marinus Pharmaceuticals, a biopharmaceutical company focused on the development of treatments for seizure disorders, announced on March 18, 2022 that FDA has approved ZTALMY (ganaxolone) for the treatment of seizures associated with CDKL5 (cyclin-dependent kinase-like) deficiency disorder (CDD) in patients two years of age and older.

CDD is a rare form of genetic epilepsy characterized by early onset, difficult to control seizures, and severe neurodevelopmental impairment. It is caused by a mutation in the (CDKL5) gene, which produces a protein that is important for normal brain development and function.

“There has been a great unmet medical need for treatments that address seizures associated with CDKL5 deficiency disorder given their prominent role and profound impact on patients,” said Scott Demarest, MD, principal investigator for the Marigold trial and neurologist and clinical director of precision medicine at Children’s Hospital Colorado. “To date, antiseizure treatment decisions have been based on very limited clinical evidence in this patient population and the resulting outcomes underscore the need for therapies that further improve seizure control. Thanks to our research and this trial, we now have the first treatment specifically approved for seizures associated with CDKL5 deficiency disorder that was shown to have a positive benefit-risk profile.”

FDA has approved ZTALMY as a treatment for seizures associated with CDKL5 deficiency disorder (CDD).

Marinus Pharmaceuticals Announces FDA Approval of ZTALMY for CDKL5 Deficiency Disorder

AstraZeneca’s antibody combination Evusheld (tixageimab co-packaged with cilgavimab) has been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA) for pre-exposure prophylaxis (PrEP) against COVID-19 in Great Britain. The medicine is intended for use in high-risk populations and in people who may not have an adequate response to COVID-19 vaccination, including those who are not recommended for vaccination.

Tixagevimab co-packaged with cilgavimab is a combination of two monoclonal antibodies given as separate sequential intramuscular injections. According to the press release, about 500,000 people in the UK are immunocompromised and may benefit from this medicine for PrEP of COVID-19. People with blood cancers and those taking immunosuppressive drugs after an organ transplant or for conditions including multiple sclerosis and rheumatoid arthritis are among the immunocompromised population that fail to generate any antibodies after vaccination.

A trial testing the efficacy of the medicine showed a statistically significant reduction in the risk of developing symptomatic COVID-19 after taking the medicine compared to the placebo. The trial showed that protection from the virus continued for at least six months. A follow-up is needed to establish the full duration of protection against the virus.

“Evusheld fills an urgent gap in the UK’s fight against COVID-19, providing protection for people for whom vaccination may not be effective and who are often amongst the most clinically vulnerable in society,” said Tom Keith Roach, president of AstraZeneca UK. “We hope to see this critical medicine made available to UK patients as quickly as possible, in line with other countries.”

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.