This column summarizes New Drug Applications (NDAs) for January-February, 2016. In these two months, FDA approved 25 NDAs.
Sixteen (64.0%) NDAs were for small molecules while the remaining nine (36.0%) were large molecules. Most of the products containing large molecules involved antibodies and related to treatment of different cancers. A total of 15 companies (60.0%) receiving NDA approvals were large companies and the remaining 10 companies (40.0%) were mid-sized and small companies. Six drug molecules were granted the Orphan Drug status (24.0%). Tablets and injections were the preferred dosage forms. Avanir Pharmaceuticals as well as Dr. Reddy’s Laboratories filed for Sumatriptan for the treatment of migraine. They received approvals for different dosage forms, an inhalation powder and an injection, respectively. Two NDA’s were approved with combination dosage forms in this quarter. Zepatier tablets (Elbasvir and Grazoprevir) and Harvoni® tablets (Ledipasvir and Sofosbuvir) were approved for Hepatitis C. Many of the molecules (68%) in this quarter were previously approved. They were approved for new indications or new dosage forms in this quarter.
Hiberix is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is now indicated for the immunization of children aged six weeks through four years (prior to 5th birthday) against invasive disease caused by Haemophilus influenzae type b (Hib).
Cosentyx® (secukinumab) has been approved for two new indications - the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). Cosentyx is now the first and only interleukin-17A (IL-17A) antagonist approved for AS, as well as moderate to severe plaque psoriasis and PsA.
Onzetra™ Xsail™ is an intranasal delivery system consisting of a low-dose (22mg) of Sumatriptan powder that is delivered utilizing the novel Xsail™ - Breath Powered Delivery Device. Onzetra™ Xsail™ is a fast-acting dry powder formulation of Sumatriptan.
Xeljanz® XR (tofacitinib citrate) is an extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). Xeljanz® XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors.
Eurofins Expands Clinical Diagnostic Footprint with the Acquisition of VRL Laboratories in the USA
Eurofins Scientific has announced the acquisition of VRL Laboratories, one of the leading laboratories in pre-transplant testing for the eligibility determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in the US.
Founded in 2010, VRL has become a reference laboratory solely focused on donor eligibility testing and microbiology testing for the transplant and medical communities. The company offers a broad menu of infectious disease screening assays to support the FDA’s 21 CFR 12711 donor eligibility determination testing requirements, specifically for eye, tissue, organ, stem cell and cord blood, as well as reproductive tissues. VRL employs a total of 60 staff across its main facility in Denver CO, and its satellite laboratories in Boston, MA, Dallas, TX, and Atlanta, GA.
The acquisition of VRL reinforces Eurofins’ footprint in specialty clinical testing services and consolidates the Group’s leadership in the transplantation testing market. Furthermore, VRL’s microbiology testing services expands Eurofins’ testing portfolio and increases client penetration in the transplantation testing market. In return, VRL will have access to the Group’s clients and competencies, as well as its laboratory network infrastructure, which should support its further development.
Comment from Dr. Gilles Martin, Eurofins CEO: “The acquisition of VRL is another demonstration of our strategy of expanding and strengthening our network of competence centers. In combination with ViraCor and Diatherix, VRL reinforces the Group’s footprint in the testing market for transplantation and infectious diseases.”
Recipharm Establishes Long Term Supply Agreement with Tillotts Pharma AG
Recipharm, the contract development and manufacturing organization (CDMO), has entered into a long term supply agreement with Tillotts Pharma AG.
The agreement comprises technology transfer and commercial manufacturing of the products Entocort and Asacol. The partnership will also involve the commercial scale development of Tillotts’ ongoing development program for TP05. All products are part of Tillotts’ dedication to innovative pharmaceutical products in the field of gastroenterology.
Recipharm will provide advanced pellet coating technology for controlled release from its facility in Pessac, France, tablet and capsule manufacturing including final packaging from its facility in Fontaine, France, and bottle filling from its site in Lisbon, Portugal. The total shared investment across the Recipharm network to enable this business amounts to €3.5 million. This includes investments to create new capacity as well as product specific investments.
The collaboration between Recipharm and Tillotts Pharma AG marks an important step in Recipharm’s full service offering strategy, allowing customers to fulfil their needs for different technologies while working with Recipharm as one full service partner. This approach allows the CDMO to simplify both the technology transfer and scale-up of projects, as well as ongoing commercial supply.
Kjell Johansson, President Manufacturing Services Europe at Recipharm, said: “We are really pleased that Tillotts Pharma AG has chosen Recipharm for these exciting products and projects. Our technical solutions offer a high level of customization and we look forward to working with Tillotts to ensure their continued development and success within the gastroenterology area.”
Mattias Norrman, COO of Tillotts Pharma AG, said: “We have undertaken a thorough evaluation process to ensure we partner with a CDMO that can meet the needs we have for project management during technology transfer and scale-up, as well as fulfilling our requirements as a reliable commercial supplier. We believe Recipharm is the ideal CDMO partner for this task and look forward to establishing a long term relationship.”
IMS Health and Quintiles Announce Key Officers for Merged Company
IMS Health Holdings, Inc. and Quintiles Transnational Holdings Inc. have announced key senior management roles in the future Quintiles IMS corporate leadership team, subject to the completion of the merger.
Senior functional leaders reporting to Chairman and Chief Executive Officer Ari Bousbib will include Michael McDonnell, EVP and Chief Financial Officer; James Erlinger, EVP and General Counsel; and Trudy Stein, EVP and Chief Human Resources Officer.
Global business leaders reporting to Mr. Bousbib will include, for the clinical research business, Tom Pike, Vice Chairman and President, Research & Development Solutions; and for the commercial business, Kevin Knightly, President, Information and Technology Solutions; José Luis Fernández, President, Global Services; Jon Resnick, President, Real-World Insights; and Scott Evangelista, President, Contract Sales Organization.
“I am proud to be part of a leadership team with deep industry knowledge, a proven track record of success and a commitment to transforming healthcare for the better,” said Ari Bousbib. “That commitment extends across the 50,000 talented professionals who will soon become part of one global team. Together, we are making excellent progress on our integration planning and are confident that we will be ready for a strong start on day one of the merger.”
Dalton Completes Major Expansion in Sterile Filling and API Manufacturing
Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider, has announced the completion of a $5 million expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.