Acceleron abandons muscular dystrophy drug

PharmaTimes | September 18, 2019

Acceleron has announced the discontinuation of the development of its drug intended for facioscapulohumeral muscular dystrophy (FSHD), ACE-083. The drug did not achieve statistically significant improvements in functional endpoints relative to placebo in a Phase II trial, which means that Acceleron will not conduct further clinical trials. Although the drug demonstrated a robust, statistically significant increase in mean total muscle volume, the primary endpoint of the trial, the increase failed to translate to statistically significant improvements in functional tests. The company says that it is “disappointed” with the results, and that it had “stated consistently, for ACE-083 to become an important new therapy for patients with FSHD, it would have to deliver a meaningful functional benefit on top of an ability to grow muscle,” said Habib Dable, President and chief executive officer of Acceleron. He continued, “Unfortunately, in this case, the data show no evidence of such a benefit and, therefore, do not support further development of ACE-083 for FSHD. We’re grateful to the patients, families, caregivers, and investigators who participated in this research.” The company also said it is “looking forward to the first quarter of next year”, as it expects topline results from the placebo-controlled Phase II trial of ACE-083 in patients with Charcot-Marie-Tooth disease—a neuromuscular disorder of different pathophysiology.

Spotlight

Upgrading to new software, such as an ERP solution, can sometimes seem like an added expense you don’t need to budget for right now.

Spotlight

Upgrading to new software, such as an ERP solution, can sometimes seem like an added expense you don’t need to budget for right now.

Related News

BUSINESS INSIGHTS, PHARMA TECH

Kindeva and Meridian Combine: Create Leading Drug-Device Combination Product CDMO

Kindeva and | December 13, 2022

Kindeva Drug Delivery and Meridian Medical Technologies announced the completion of the transaction to combine the two companies. The combination has created a leading global contract development and manufacturing organization focused on drug-device combination products. The combination will operate under the Kindeva name, with Meridian operating as, “Meridian Medical Technologies, a Kindeva Company”. The new Kindeva will have a broader range of drug delivery capabilities, with expertise and technology spanning the parenteral, inhalation, transdermal, and intradermal routes of administration. Milton Boyer, formerly the CEO of Meridian, has been named CEO of the newly combined company. “The combination of Kindeva and Meridian creates a clear market leader in the drug-device CDMO sector. Customers will benefit from our enhanced scale and broader array of drug delivery solutions,” Boyer Kindeva, formerly known as 3M Drug Delivery Systems, was acquired by Altaris, LLC in 2020 from 3M Company. Kindeva is a global leader in drug-device combination products with a focus on inhalation, transdermal, and intradermal drug delivery. The company has a long track record of innovation, having invented the first metered dose inhaler in the 1950s. Meridian was acquired by Altaris in December 2021 from Pfizer Inc. Meridian is a leading manufacturer of emergency autoinjectors, having pioneered the emergency autoinjector technology in the 1950s. Meridian owns over 300 patents related to autoinjector drug-device combination products. ArentFox Schiff LLP and Kirkland & Ellis LLP acted as legal counsel. JPMorgan Chase Bank, N.A., Truist Securities, Inc. and KeyBanc Capital Markets Inc. acted as joint lead arrangers for the transaction. About Kindeva Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including autoinjectors, inhalers, transdermal patches, and microneedles. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing and drug-device product assembly. Kindeva serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K. About Altaris, LLC Altaris is a healthcare investment firm with an exclusive focus on building companies that deliver value to the healthcare system through innovation and efficiency. Since inception in 2003, Altaris has invested in 49 healthcare companies which have generated significant value appreciation for its investors. Altaris is headquartered in New York City and manages approximately $5 billion of equity capital.

Read More

PHARMACY MARKET

Nephron and Sharps Announce Manufacturing and Research Partnership

Nephron Pharmaceuticals Corporation | November 15, 2022

Nephron Pharmaceuticals Corporation and Sharps Technology, Inc. announced a brand new partnership focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the InjectEZ component of expansion. Sharps Technology is a medical device and pharmaceutical packaging company specializing in developing and manufacturing innovative drug delivery systems. Nephron Pharmaceuticals is known across the country to health systems and hospitals as a leader in the production of affordable generic inhalation solutions and suspension products, as well as pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags. InjectEZ is part of the Nephron investment of hundreds of millions of dollars of expansion in Lexington County, S.C., over the last two years. Lou Kennedy, Nephron CEO, knows that when launching an endeavor as ambitious as InjectEZ, partnerships are key. "We are excited to kick off a partnership with Sharps Technology, as our InjectEZ expansion project opens, for a variety of innovative initiatives, including research and development," said Kennedy. "Just as the InjectEZ syringe manufacturing facility is poised to play a critical role in assisting those with whom we work on tackling emerging public health crises, Sharps Technology also offers key solutions to healthcare challenges. We look forward to working with them." Sharps product lines have historically focused on low waste and ultra-low waste syringe technologies, which allow up to 40% more injections per vial of therapy while incorporating multiple passive safety features. These features protect front-line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. The partnership with Nephron opens up opportunities for Sharps to expand its portfolio and make an impact on the specialized pre-fillable syringe and drug delivery systems market. "Sharps Technology has identified a unique opportunity to collaborate with a leader in the industry like Nephron. Through my previous industry experience supporting and working with most of the leading healthcare and pharmaceutical companies in the world, it was easy for me to evaluate Nephron Pharmaceuticals as a potential partner. They truly are a leader in all areas of business and an example of best in class for the industry. I appreciate and look forward to the opportunity to work with Bill and Lou Kennedy and their leadership team to make this collaboration a success for both companies." Robert Hayes, CEO of Sharps Technology Sharps Technology brings extensive expertise in syringes to Nephron, including experience with specialized pre-filled syringe systems and ready-to-use processing. The pre-filled syringe lines will utilize the highly automated equipment and controlled environments established by Nephron. These premium pre-filled polymer offerings will be made from the highest quality raw materials, on the most innovative technology, and will be compliant with the USP standards required in the United States as well as the EP and JP international standards. The products that will be developed and commercialized provide solutions to support the current Nephron fill/finish strategies as well as their pipeline of new drug applications and sets forward a strategy to support branded pharma and advanced therapies, including ophthalmic and biologic applications. Sharps Technology will also be partnering with Nephron Pharmaceuticals in the development of a Pharmaceuticals Services Program designed to support healthcare customers that need innovative solutions and products to support their business. The development of this program will help create new fill/finish project opportunities for Nephron that will utilize innovative packaging solutions developed by Sharps Technology. These new customer projects will fuel the growth of both companies, and the opportunity to create new technologies to support the healthcare industry will be transformative for Nephron and Sharps as they navigate a bright future working together.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

TherapeuticsMD Announces Definitive Agreements to License its Products to Mayne Pharma

TherapeuticsMD, Inc. | December 05, 2022

TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into definitive agreements to license its products to an affiliate of Mayne Pharma Group Limited an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, for commercialization in the United States. In addition, TXMD has agreed to sell certain assets to Mayne Pharma to allow Mayne Pharma to commercialize the products. At closing of the transaction, TXMD will receive an upfront cash payment of $140.0 million for the license grant and sale of certain assets, plus an additional approximately $13.1 million, subject to customary adjustments, for acquired net working capital. In addition, TXMD will receive a 20-year royalty stream tied to Mayne Pharma’s net sales of the products. The upfront payment to be made by Mayne Pharma, along with cash on hand, will allow TXMD to repay its outstanding indebtedness with Sixth Street Partners and to redeem its outstanding preferred equity, with TXMD continuing as a pharmaceutical royalty company with the potential to create value for stakeholders over time from the resulting net cash flows. "After completing a thorough evaluation of several strategic alternatives, our Board of Directors concluded that this transaction with Mayne Pharma would create the most value for TherapeuticsMD’s stakeholders. This transaction will allow us to repay in full our debt to Sixth Street Partners and redeem our preferred stock from Rubric Capital Management, while also establishing a future royalty revenue stream for our common shareholders. We believe that Mayne Pharma has the experience necessary to fully realize the promise of our products as we work together to improve patient care.” The Honorable Tommy Thompson, Executive Chairman of TherapeuticsMD Upon completion of the transaction, which is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Act of 1976, Mayne Pharma will be responsible for development, regulatory filings, manufacturing, and commercialization of the Products. TXMD will receive an upfront payment of $140.0 million for the sale of the assets and the grant of the licenses, plus a payment of approximately $13.1 million for the acquisition of net working capital, subject to certain customary adjustments. In addition, Mayne Pharma will make one-time, milestone payments to the Company of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million. Further, Mayne Pharma will pay to the Company royalties on net sales of all licensed Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the closing. The royalty rate will decrease to 2.0% on a Product-by-Product basis upon the earlier to occur of the expiration or revocation of the last patent covering a Product and a generic version of a Product launching in the United States. Mayne Pharma will pay to the Company minimal annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments. In connection with entering into the transaction, the lenders and administrative agent under the Company’s Financing Agreement with Sixth Street Partners have agreed to extend the maturity date of the Financing Agreement to December 31, 2022, allowing the Company to complete the transaction with Mayne Pharma on or before that date. The maturity date of the Financing Agreement may be further extended to January 31, 2023, upon payment of an amendment fee, in the event the definitive agreements in connection with the transaction remain in effect and the waiting period under the HSR Act has not expired or terminated. The Company will retain its existing licensing agreements with Knight Therapeutics, Inc. and Theramex HQ UK Limited. The transaction is not subject to any financing conditions and is expected to close at the end of 2022, pending satisfaction of customary closing conditions. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues.

Read More