News Briefs


Breckenridge obtains FDA OK for generic Zavesca

Pill bottles with white pills

Breckenridge has obtained approval from the Food and Drug Administration for Miglustat capsules in a dosage strength of 100 mg. 

The medication, a generic of Zavesca, is used to treat adults with mild to moderate Type 1 Gaucher disease and will be commercialized by a U.S.-based manufacturer, the company said. 

In addition, Breckenridge plans to launch miglustat capsules during the third quarter of 2022 in a 90-count bottle. 

Zavesca and its generics had a market value of $15 million during the 12 months ending February 2022, according to industry data.


Hikma acquires Custopharm

Hands transferring a company

Hikma has completed its acquisition of Custopharm from Water Street Healthcare Partners, following approval from the Federal Trade Commission.

As previously announced on Sept. 27, 2021, the company acquired Custopharm for an initial cash consideration of $375 million on a debt and cash-free basis, with a further $50 million in contingent consideration payable upon the achievement of certain commercial milestones.  

Hikma noted that the company is the second-largest supplier by volume of generic sterile injectable medicines used by US hospitals and health care providers. The combination with Custopharm enhances Hikma’s R&D capabilities and pipeline and expands Hikma’s differentiated U.S. portfolio to close to 130 commercialized injectable medicines — a more than fivefold increase over the last decade.

In addition, the company shared that the acquisition complements its product portfolio and pipeline, adding up to 13 approved products and additional pipeline products, and enhances R&D capabilities, adding an experienced scientific team of dedicated R&D professionals with a proven ability to develop and commercialize complex sterile injectable products and a state-of-the-art R&D laboratory in California.

The acquisition also maintains Hikma’s strong regulatory track record. Custopharm has consistently obtained regulatory approval for new products with four first-to-market FDA ANDA approvals, including one CGT exclusivity for Calcitonin Salmon, which was launched in May 2021.

“The acquisition of Custopharm immediately strengthens our already strong U.S. injectables business by adding an attractive and profitable portfolio of marketed products, an exciting pipeline of future opportunities and a first-class scientific team with a strong regulatory track record," said Hikma CEO Siggi Olafsson. “This acquisition is highly complementary to our existing business and places us in an excellent position to better serve the growing needs of hospitals, doctors and patients. I am excited to welcome the team at Custopharm to Hikma as we continue to grow and strengthen our injectables business.”


Chloe’s debuts frozen pop varieties

chloe's frozen pops

Chloe’s continues to innovate the nondairy frozen novelty aisle with a new launch.

The brand is rolling out its new Marvel-inspired SKUs — tangy lemon-lime and orange variety packs, which feature the characters of Spider-Man and Ghost-Spider, and strawberry-mango pops with Avengers characters Thor, Doctor Strange, The Falcon and Captain Marvel.

In addition, Chloe’s is welcoming a no sugar option of its juice grape flavor, the company said.

“We are proud to expand our collection with Marvel and offer new varieties with the beloved Spider-Man and Avengers characters that span generations,” said Chloe’s president and co-founder Chloe Epstein. “All of our pops are made of the highest quality ingredients and are free from all the artificial stuff we want to avoid, but still offer an authentic, delicious, nostalgic experience. Both our new Marvel and No Sugar Added Pops are further extensions of our commitment to making better-for-you frozen treats more accessible for all.”

Consumers can find Chloe’s Spider-Man strawberry-lemon pops and Avengers cherry and grape variety packs at such retailers as Publix, Whole Foods Market, Sprouts, Jewel-Osco, Safeway, Albertsons, United, Market Street, Meijer, Giant Food, Giant, Stop & Shop, Price Chopper, Fresh Direct, Winco, Raley’s, Giant Eagle, Harris Teeter, Winn-Dixie, Family Fare, Martin’s, D&W and Fresh Thyme among others.

The no sugar added grape pops, which are made without any artificial ingredients, can be found at Sprouts, Raley’s, Winn-Dixie, United, Market Street, Giant, Martin’s and Fresh Direct among others.


Long Grove Pharmaceuticals to intro generics products


There’s a new player introducing products in the generics market.

Long Grove Pharmaceuticals, founded in 2019 by strategic healthcare investor Water Street Healthcare Partners, announced that it will begin shipping its first products in mid-2022.

Long Grove bills itself as a company that "specializes in generic development opportunities with complex formulations, challenging manufacturing and supply chain dynamics, and unique regulatory approval pathways.”

The company shared that it is spearheaded by a multifunctional team of leaders with more than 100 years of collective pharmaceutical experience. “Together, they are pursuing partnership and product development initiatives focused on bringing long-awaited products to market across the hospital pharmacy, retail, clinic and alternative site channels,” the company said.

“The depth of our team’s expertise provides us with a specialized understanding of how to rapidly scale complex formulations and bring to market products known for having high barriers to entry,” said CEO Dan Robins. “We are deeply committed to leveraging our knowledge and network to cultivate needed solutions across the generics market that will improve customer choice and increase patient access.”

Long Grove Pharmaceuticals said that it employs the ANDA regulatory pathway to enable more rapid product approvals. It also develops proprietary products through the 505(b)(2) regulatory pathway. The company utilizes a variety of established manufacturers in North America, Western Europe and Asia.

The company also said it expects to innovate across the generic injectables, dermatological and topical markets.


Hostess adds mint chocolate flavor to Cr!spy Minis line

hostess Cr!spy Minis mint chocolate

A new flavor has joined Hostess Cr!spy Minis line of bite-sized snacks.

The new addition is mint chocolate, which combines mint and cocoa to create a creamy texture, the Lenexa, Kan.-based company said.

“Consumers are increasingly craving multitextured snacks, and this trend was central to the original launch of our Cr!spy Minis,” said Christopher Balach, general manager of Hostess Brands. “We’re excited to add another delicious flavor to this creamy-crunchy lineup of unique and innovative snacks.”

Featuring two layers of a creamy refreshing mint filling between crisp wafers topped with a chocolate-flavored layer, the Cr!spy Minis are made with real mint and cocoa and are free of high fructose corn syrup and artificial colors and flavors, the company said.

Available in a resealable 7.3-oz. package, Hostess Cr!spy Minis in mint chocolate retails for $3.49 and can be found at retailers nationwide.


Cardinal Health names Megan Maltenfort to lead environmental, social and governance

A puzzle piece with a stick figure.

Cardinal Health is welcoming a new executive. Megan Maltenfort is joining the company as vice president of environmental, social and governance.

“We are pleased to welcome Megan to the Cardinal Health family,” said Jessica Mayer, chief legal and compliance officer.  “With her deep expertise in sustainability, Megan will be a strong partner in helping guide our enterprise sustainability strategy while also engaging with employees and external stakeholders on initiatives and opportunities.”

"As a global company, we know that the long-term health of our employees, customers, partners and communities depends on a healthier, more sustainable and equitable world … and that ESG priorities are more critical than ever to our shared future," Cardinal Health said.

“I am excited to join the Cardinal Health team,” Maltenfort said. “I look forward to partnering with employees across Cardinal Health and furthering the company’s efforts in caring for our people, our communities and our planet.”

Maltenfort brings a wealth of experience from her 15-year career in sustainability. Most recently, she served as director of corporate responsibility and sustainability at Campbell Soup, where she led the co-creation of Campbell’s enterprise-wide ESG strategy; external corporate responsibility reporting; stakeholder management with investors, NGOs and customers; and more.

Prior to Campbell Soup, she first became familiar with Cardinal Health during her time with VWR International, which at the time was a distributor of laboratory supplies, and which since has been acquired by Avantor. Here she built a leading ESG program from the bottom up, helped develop a first-of-its-kind lab product recycling program and used sustainability as a competitive advantage to position VWR as a partner of choice among its customers, Cardinal Health said.