Global Pharma Briefs: News from Asia, Europe, and the USBy
A roundup of news from Japan (Fujifilm), the UK (BI, Hikma, Perrigo) and the US (Nabriva Therapeutics, Lupin, Unichem, GSK, and La Jolla Pharmaceuticals).
Fujifilm Announces Approval of Adalimumab in Japan
Fujifilm Kyowa Kirin Biologics, a biosimilars company of Fujifilm, has received manufacturing and marketing approval in Japan for the biosimilar, adalimumab, a reference product to AbbVie’s Humira (adalimumab). Humira had 2019 sales of approximately $19.2 billion.
In Japan, Fujifilm Kyowa Kirin Biologics is the marketing authorization holder, and Mylan will be in charge of the commercialization of the product. Fujifilm Kyowa Kirin Biologics entered into a partnership with Mylan in 2018 for the commercialization of the biosimilar adalimumab in Europe and expanded the partnership globally in 2019. To date (as reported on June 29, 2020), Mylan has commercialized the product as Hulio in over 20 countries across Europe. Fujifilm Kyowa Kirin Biologics says it will continue to work obtaining marketing approvals in other countries.
BI To Sell Stake in Hikma; Hikma To Buy Back Shares
Hikma, a London-headquartered pharmaceutical company, reports that Boehringer Ingelheim (BI) has announced its intention to exit its full iinvestment in Hikma Pharmaceuticals. As of June 22, 2020, BI holds 40 million ordinary shares in Hikma, which represents approximately 16.4% of the issued ordinary share capital and voting rights in the company.
Hikma says it plans to buy back from BI approximately 28 million shares for an aggregate value of £295 million ($366 million). The value represents approximately 4.99% of the aggregate market value of all the shares of Hikma.
Hikma has separately entered into an agreement with BI under which Hikma will receive a commitment fee of 2% of the aggregate value of the buy-back shares acquired at the buy-back price.
Hikma will fund the buy-back from cash and available facilities. Hikma says it intends to hold the buy-back shares in treasury and will not receive any proceeds from the placing. Following the successful completion of the placing and the buy-back, BI would no longer hold any shares in Hikma.
The shares being sold by Boehringer Ingelheim were issued by Hikma as part of the consideration for BI’s acquisition of Roxane Laboratories in February 2016.
Perrigo to Divest Generic Drug Business for $194 M
Perrigo, a pharmaceutical company of generic drugs and over-the-counter (OTC) products, has agreed to sell its UK-based Rosemont Pharmaceuticals business, a generic prescription pharmaceuticals manufacturer focused on liquid medicines, to a UK-headquartered private equity firm for £156 million ($194 million).
FDA Issues Complete Response Letter to Nabriva for UTI Treatment
Nabriva Therapeutics, a Dublin, Ireland-based biopharmaceutical company focused on anti-infective agents, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the company’s new drug application (NDA) resubmission seeking marketing approval of Contepo (fosfomycin), an injection indicated for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
Nabriva says the CRL cites observations at its manufacturing partners that could not be resolved due to the FDA’s inability to conduct onsite inspections because of travel restrictions. Previously identified product-quality and facility-inspection-related observations at Nabriva’s contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of Contepo in the CRL.
Nabriva says it plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDA’s plans for completing foreign-facility inspections. Contepo has been granted qualified infectious disease product and fast track designations by the FDA for the treatment of serious infections, including cUTI.
Source: Nabriva Therapeutics
Lupin, Unichem Recall Blood Pressure Drugs
Unichem Laboratories, a Mumbai, India-based pharmaceutical company, and Lupin Pharmaceuticals, a Mumbai, India-based pharmaceutical company, have separately voluntarily recalled batches of high-blood pressure drugs from the US market due to quality issues, according to the US Food and Drug Administration’s Weekly Enforcement Report of June 17, 2020.
The US-based arm of Lupin is issuing a Class II recall of 4,224 bottles of lisinopril tablets, (prescription, 5 mg, packaged in a 1,000-count bottle) in the US due to product mix-up in which lisinopril 10-mg tablets were found in lisinopril 5-mg 1,000-count bottle. A Class-II recall is initiated in a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Unichem Pharmaceuticals (USA), the US-based arm of the company, is issuing a Class III recall of 190,992 bottles of clonidine hydrochloride tablets (prescription, 0.1 mg, packaged in a 100-count bottle) in the US due to failed tests for impurities and degradation, specifically for potential migration of benzophenone at very low levels into the product from the container. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Source: US Food and Drug Administration
GSK Issues Recall of Children’s Cold and Cough Drugs
GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling to the retail level two lots of Children’s Robitussin Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp Cold and Cough due to the inclusion of incorrect dosing cups.
During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children’s Robitussin Honey product are missing the 5-mL and 10-mL graduations while the dosing cups for the Children’s Dimetapp product are missing the 10-mL graduation. The dosing cups packaged with both products only have the 20-mL graduation.
The FDA says there is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered
As of the date of the recall announcement (June 18, 2020), GSK Consumer Healthcare says it has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product.
These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the US. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product.
Source: US Food and Drug Administration
La Jolla Pharmaceutical to Acquire Tetraphase for $59 M
La Jolla Pharmaceutical, a San Diego, California-based pharmaceutical company, has agreed to acquire Tetraphase Pharmaceuticals, a Watertown, Massachusetts-based pharmaceutical company, in a deal worth up to $59 million ($43 million upfront and up to $16 million in potential future payments).
Under the merger agreement, La Jolla would acquire Tetraphase, through a tender offer, for $43 million in upfront cash plus potential future cash payments of up to $16 million pursuant to contingent value rights. The Board of Directors of Tetraphase has unanimously recommended that stockholders tender their shares in the La Jolla tender offer once it is commenced. Any shares not tendered in the tender offer will be acquired in a second-step merger at the same cash price as paid in the tender offer.
Closing of the transaction is subject to specified closing conditions, including that a majority of Tetraphase’s shares of common stock are validly tendered and not validly withdrawn. Upon the closing of the transactions, Tetraphase will become a wholly owned subsidiary of La Jolla. The transaction is expected to close in the third quarter of 2020.
On June 24, 2020, Tetraphase terminated its previously announced merger agreement with Melinta Therapeutics, a Morristown, New Jersey-based pharmaceutical company. In connection with the termination of the definitive merger agreement with Melinta, Tetraphase paid Melinta a termination fee of $1.15 million.
Source: La Jolla Pharmaceutical, Tetraphase Pharmaceuticals, and Melinta Therapeutics