Perrigo ANDA Approval Brings New Options To Generic Mucinex DM Maximum Strength Portfolio

Perrigo's first OTC drug approved in 2018 is extended-relief guaifenesin 1,200 mg and dextromethorphan 60 mg tablets, planned for launch under its own store brand, Goodsense, as well as distribution for retailer and private label brands. It already distributes the product for store and private label brands through an agreement with Teva.

 Perrigo Co. PLC has been providing US retailers and other customers with extended relief guaifenesin 1,200 mg and dextromethorphan 60 mg tablets for the past few years under an agreement with Teva Pharmaceutical Industries Ltd., but now has new options with the approval of its own ANDA for the product.

The product indicated to control coughs and break up mucus is a generic equivalent of Reckitt Benckiser Group PLC's Mucinex DM Maximum Strength, which had sales of $128m for the most recent 12-month period measured by market research firm IRI, Perrigo said. Perrigo hopes its first OTC drug approval in 2018 will help drive more than $300m in new product sales it forecasts for 2018, although most of that growth is expected to come from from Rx generics launches.

But the approval announced March 7 appears to give Perrigo the ability to include the product under its own store brand. The company isn't indicating whether or how the approval could impact its agreement with Teva: whether it could opt to go it alone with the Perrigo-manufactured product or continue to include Teva-supplied product as part of its range of offerings in this area.

The Ireland-incorporated firm plans to distribute the product for retailers' store brands and marketers' private label lines and to also launch it under its "wholly owned store brand,” which is GoodSense available on Amazon and from some discount retailers.

Perrigo has been providing retailers and other customers with guaifenesin 1,200 mg/dextromethorphan 60 mg extended-release tablets made for it by Teva and that it launched in 2016 as the first generic of the formulation to reach the market. (Also see "Private Label Mucinex March Reaches Two Formulations" - Pink Sheet, 4 May, 2016.) The firm declined to comment on whether it will continue distributing the product made by Teva.

Some private label and store brand versions of the product already available are distributed by Perrigo but are labeled as manufactured under an abbreviated new drug application approval FDA made in 2015 for Actavis Labs FL Inc., part of Allergan PLC before Teva acquired Allergan's consumer business.  (Also see "Teva Seeds OTC Growth Synergies With Former Allergan Business" - Pink Sheet, 14 Sep, 2016.)

The firm, which maintains its primary operations in Allegan, Mich., turned to manufacturing partners for multi-ingredient Mucinex generics after a rocky start to its own production of an equivalent of the expectorant brand's original single-ingredient version. A limited launch in 2012 ended after raw material sourcing did not meet specifications and production stalled for more than two years until supply problems were resolved. Perrigo began distributing the product broadly in late 2014 before again pausing in early 2015 due to problems with an excipient. (Also see "Private Label Mucinex March Reaches Two Formulations" - Pink Sheet, 4 May, 2016.)

Perrigo received FDA approval in 2016 for guaifenesin 600mg/dextromethorphan 60mg, a generic of regular strength Mucinex DM. It also distributes guaifenesin 600 mg and pseudoephedrine 60 mg tablets, equivalent of Mucinex D, indicated for nasal congestion and as an expectorant, and it offers GoodSense Mucus Relief (400 mg guaifenesin), an OTC generic of the original Mucinex expectorant formulation.

In addition to Actavis' ANDA, Aurobindo Pharma Ltd. in March 2017 received approval for extended-release guaifenesin 1,200 mg/dextromethorphan 60 mg tablets in March 2017, according to FDA records. Mucinex DM was approved as an OTC switch in 2004 for Adams Respiratory Therapeutics Inc., which Reckitt acquired in 2007.

Slow 2018 Forecast For Consumer Health Sales

Perrigo reported March 1 that net sales for its North American consumer products division, comprising private label, store brand and GoodSense OTCs, adult and infant nutritional formulas and animal health products, grew 2.5% to $644m in the 2017 fourth quarter and full-year sales grew 1.4% to $2.5bn.

The firm forecasts growth in 2018 for the segment's OTC drug and infant formula sales but its guidance is tempered by the loss of some animal health business revenues. Net sales for the segment are expected to grow around 1% to $2.4bn, while it expects sales for its international branded OTC and nutritional product business flat at $1.56bn.

Its Rx segment fourth-quarter sales were off 1.7% from the year-ago period to $261m and down 7% for the year to $969.7m. But Perrigo looks to the division to lead its sales growth in 2018, forecasting full-year net sales growing 9% to $1.06b. It highlighted as key drivers the expected approval of generics of Teva's ProAir HFA (albuterol) metered-dose inhaler asthma treatment and the expected launch of AbbVie Inc.'s Androgel Topical Gel (testosterone 20.25 mg/1.25 g packet and 40.5 mg/2.5 g packet) for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, for which it received approval in July 2017.

It already has received FDA approval in 2018 for two Rx drugs. A generic of Allergan's Estrace Cream (estradiol vaginal cream, 0.01%), for treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, was approved in February and will be marketed by Impax Laboratories Inc., with a second-quarter launch expected. In January, it received approval for and launched a generic of Galderma Laboratories LP's Epiduo (adapalene and benzoyl peroxide/gel, 0.1%/2.5%) indicated for topical treatment of acne vulgaris in patients 9 and older.  

During the firm's March 2 earnings presentation, recently appointed President and CEO Uwe Rohrhoff said it is undertaking a “value creation analysis” of its business units, as the Rx business showed improvement in the quarter after a difficult year. The Rx business could be essential for the company because US competition for smaller, online brands is in increasing in the OTC drug space and sales of Perrigo’s consumer health products in Europe have yet to reach expectations. (Also see "Perrigo Finding Balance As Three-Legged Stool With Two Consumer Units, Rx Division " - Pink Sheet, 5 Mar, 2018.)

In a March 4 research report, BTIG analyst Timothy Chiang says Perrigo’s shares could benefit if Rohrhoff is able to further streamline its global supply chain. “We think the main challenge the [company] faces is finding a way to grow the [company’s] OTC segments (within the US and internationally) without having to make another major acquisition,” Chiang said.

When Perrigo announced Rohrhoff’s appointment Jan. 8, analysts responded optimistically to his experience leading the complex supply chain of Gerresheimer AG, a manufacturer of primary packaging products for medication and drug delivery. As Gerresheimer CEO, he oversaw 36 manufacturing facilities across 14 countries, product distribution to 1,500 customers including the 10 largest pharmaceutical companies in nearly 100 countries, according to Perrigo.  (Also see "Perrigo Taps CEO With Global Operations Expertise At Pharma Packaging Firm" - Pink Sheet, 8 Jan, 2018.)

From the editors of The Tan Sheet.