BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | May 04, 2023
Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and H&T Presspart have entered in a strategic partnership to advance the development of Presspart's Sunriser© Capsule-based Dry Powder Inhaler platform. The demand for inhalable drugs that require higher drug loads and the delivery of cohesive materials has increased, making it necessary to develop more efficient solutions. To meet this demand, the two companies will work together to develop the Sunriser© Dry Powder Inhaler. This innovative and best-in-class capsule-based platform is flexible enough to address both the challenges of classic carrier-based and spray-dried engineered formulations.
This partnership is an extension of a successful collaboration that has spanned several years on developing and commercializing innovative dry powder inhalation devices. As part of the joint development agreement, Hovione will exclusively partner with Presspart to exploit the Sunriser© device in the field of engineered formulations for dry powder inhalation. Presspart will remain responsible for the manufacturing of the Sunriser© device. To provide further insights into the benefits of this partnership for the industry, a joint workshop will be held today, May 3rd, at the Respiratory Drug Delivery (RDD) Europe 2023.
"New inhalable therapies are often requiring delivery of higher doses of cohesive and sensitive powders. Our priority is to ensure maximum efficiency in delivering these drugs to the right locations in the lung," says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds: "We are thrilled to expand our current partnership with Presspart and combine our expertise in the fields of engineered particles and inhalers for the benefit of our customers and patients."
Christian Kraetzig, President of H&T Presspart, commented "Following our successful collaboration with Hovione on the PowdAir Plus DPI device development, we are once again extremely pleased to be working with Hovione in developing this next generation high performance DPI device. As the market leader in respiratory components and devices, this strategic partnership will allow H&T Presspart to expand its portfolio within the growing field of dry powder technology."
Pharmaceutical companies partnering with Hovione to develop their new inhalable drugs using the Sunriser© device can leverage Hovione´s unparalleled expertise in inhalable APIs, formulation, filling, and analytical characterization. Additionally, with H&T Presspart's state-of-the-art device manufacturing and supply, from lab to commercial cGMP scale, companies can benefit from a comprehensive approach to drug development. This partnership enables pharmaceutical companies to access top-notch expertise and cutting-edge technology, ensuring the successful development and commercialization of innovative inhalable drugs.
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices.
BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | May 10, 2023
AustinPx, a contract development and manufacturing organization (CDMO) specializing in analytical and formulation development services and cGMP manufacturing for small molecule drugs, today announced the expansion of its capabilities to meet industry demand for the Company’s services and expertise. The Company has added new spray drying and encapsulation capabilities and has also expanded its GMP manufacturing capacity for high shear and fluid bed granulation.
AustinPx has installed and validated a Dott. Bonapace INCAP capsule filler, a Freund-Vector VFC3 model fluid bed, and a Freund-Vector GMXB-Pilot model granulator. The INCAP rounds out the Company’s solid dose manufacturing capabilities, while the fluid bed and granulator supplement the Company’s manufacturing scale.
“The investments are a key component of AustinPx’s larger strategy to expand our oral dose development and manufacturing capabilities to better serve our clients’ increasing demand,” said Justin Keen, PhD, senior vice president operations. “The additions demonstrate our ongoing commitment to providing our clients with the best possible service and support."
In line with the Company’s mission of providing science-driven formulation development, AustinPx has installed a PROCEPT modular 4M8-Trix for the development of spray dried amorphous solid dispersions. The addition supplements AustinPx’s current portfolio of bioavailability enhancement technologies, including KinetiSol® Technology - the Company’s proprietary fusion-based amorphous dispersion manufacturing platform.
“We are excited to add spray drying to our portfolio,” said Dave Miller, PhD, chief scientific officer. “When combined with our existing formulation capabilities, the addition enables us to provide a comprehensive suite of bioavailability enhancement solutions to identify the optimal formulation pathway for poorly soluble compounds and address a greater number of our clients’ challenges.”
The expanded capabilities are now available for use. These additions are the first of several strategic investments planned for the Company in the immediate future, as AustinPx continues to position itself as a leading CDMO in the pharmaceutical industry.
AustinPx, Pharmaceutics and Manufacturing, is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.
BUSINESS INSIGHTS, PHARMACY MARKET
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.