Teva's rating cut to junk, Two Lupin facilities receive FDA warning letters

Teva’s rating cut to junk; Two Lupin facilities receive FDA warning letters

This week in Phispers, we look at the contrasting 2017 forecasts of Mylan and Teva, resulting from the FDA approval of Mylan’s generic Copaxone. Valeant decides to return the female libido pill business to Sprout Pharma. In India, two Lupin facilities receive FDA warning letters. And Torrent Pharma’s imminent acquisition of Unichem is set to make it the country’s fifth largest drug company. Meanwhile, Pfizer admits to have faltered on integrating Hospira and QuintilesIMS rebrands itself as IQVIA.

Teva’s credit rating nosedives, as Mylan raises 2017 forecast with approval of Copaxone

Here’s the tale of two drug makers — Teva Pharmaceutical Industries and Mylan NV. Both have been facing tough times — Teva due to the declining prices of drugs and the high debt it incurred due to its US$ 40 billion acquisition of Allergan Plc’s generics business last year; and Mylan due to its struggles with its blockbuster emergency allergy shot EpiPen.

But last week clearly favored Mylan. Teva saw its credit rating cut to junk by Fitch Ratings after the US Food and Drug Administration (FDA) approved two doses of Mylan’s generic version of Teva’s Copaxone. This multiple sclerosis drug happens to be Teva’s biggest product. As a result, Teva slashed its 2017 profit forecast for a third time.

Fitch predicted that Teva will have to either sell assets or find external sources of financing to meet its obligations. Mylan, on the other hand, raised its 2017 forecast as it expects to benefit from the ‘earlier-than-expected approval’ of its generic Copaxone.

Even as Mylan hopes to benefit from its generic Copaxone, its challenges continue unabated. Its third-quarter results highlighted the company's struggles with declining sales of EpiPen. Sales of EpiPen fell by US$ 245.1 million on increased competition and higher governmental rebates following a settlement with the US Department of Justice.

EpiPens, which contain the hormone epinephrine, are used to stave off allergic reactions that can be fatal. However, since mid-September this year, seven people have died as a result of failure of EpiPens to deploy correctly. In all, the FDA has received 228 reports of EpiPen or EpiPen Jr failures since mid-September.

Teva’s JV with Guangzhou: Meanwhile, Teva is exploring growth through the world’s second-largest market for drugs — China. It is setting up a joint venture with Guangzhou Pharmaceutical Holdings to manufacture and sell its drugs in the Chinese market. It is awaiting approval from the local government.

Two years after buying ‘female-Viagra’, Valeant plans to sell it back to Sprout

After buying the female libido pill business from Sprout Pharmaceuticals two years back for US$ 1 billion, this week Valeant Pharmaceuticals International said it plans to sell the business back to its original owner.

The controversial pink pill — Addyi — made by Sprout was said to be a blockbuster drug, expected to command a US$ 2 billion market. However, Addyi proved to be a commercial disaster, with its sales being sluggish last year. What was worse, Valeant was sued on behalf of the former Sprout investors for its alleged failure to market Addyi successfully. The complaint had said that sales of the pill may have totaled less than US$ 10 million in 2016, far short of the US$ 1 billion targeted by July, 2017.

Addyi, approved by the US FDA in August 2015 under intense pressure from patient advocacy groups, is meant to be taken daily. It is prescribed to activate sexual impulses, but carries a strong warning about its potential side effects — such as low blood pressure and fainting, especially when taken with alcohol. Many in the industry believe that the drug should never have been approved.

Valeant has agreed to sell its subsidiary and Addyi to a new company “associated” with Sprout’s founders, for a royalty stream of only 6 percent on global sales of Addyi. In addition, Valeant said it will provide a US$ 25 million loan to fund initial operating expenses to the new company to get things started. And in exchange, Sprout is dropping its lawsuit claiming Valeant mismanaged the launch by pricing the drug too high.

Valeant’s glaucoma drug: Last week, the US FDA approved Valeant’s long-delayed glaucoma drug — latanoprostene bunod ophthalmic solution.

Christened Vyzulta, the solution was approved for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma. Valeant hopes to have the drug in the market before 2017-end, Joseph Papa, CEO of Valeant, said in a statement.

Valeant acquired the drug through its US$ 8.7 billion buyout of Bausch + Lomb in 2013. The drug was licensed to Bausch + Lomb by France-based Nicox.

Torrent to emerge fifth-largest Indian drug player after Unichem buyout

In India, Ahmedabad-headquartered Torrent Pharmaceuticals plans to acquire Unichem Laboratories’ domestic business for US$ 558 million (Rs 36 billion) by the end of this week.

The deal would make Torrent the fifth largest player in the Indian market with a market share of 3.4 percent. According to a Reuters report, Torrent would buy more than 120 brands from Unichem in India and Nepal, along with its manufacturing plant in Sikkim.

The board of Torrent is meeting on November 10 to approve the second quarter results. A formal announcement on the acquisition of Unichem is likely to come on that day.

Unichem has not been able to leverage its slow-growing, mature brands. The deal includes the purchase of the brands like Unienzyme, Losar, Ampoxin and Telsar.

The acquisition is likely to deliver synergies in both cost and revenues for Torrent’s branded drugs business in India. Torrent is expected to turnaround Unichem’s mature brand, just the way it had turned around Elder Pharma’s branded formulations, which it had acquired in 2014 for US$ 308 million (Rs 20 billion).

Analysts expect Unichem to use the proceeds from the deal to ramp up its unprofitable international business. The transaction will strengthen Torrent’s position in cardiology, diabetology, gastro-intestinals and central nervous systems therapies, Torrent chairman Samir Mehta said.

Despite record profits, Pfizer’s CEO says troubles with Hospira persist

American pharmaceutical giant Pfizer reported third-quarter profits last week, which more than doubled as its new drugs to treat cancer and other illnesses made up for the hit the company took due to patent expirations.

Pfizer’s net income from the quarter stood at US$ 2.8 billion, compared with just under US$ 1.4 billion in the year-ago period.

However, Pfizer’s Essential Health unit remained an area of concern, into which Hospira was folded. The third quarter revenue of this unit was down 11 percent, at US$ 5.06 billion. Pfizer had acquired Hospira in 2015 for US$ 15 billion.

While praising other parts of the Essential Health unit (such as biosimilars and emerging markets), Pfizer CEO Ian Read pointed his finger at Hospira. “Within our Essential Health portfolio, we have been experiencing supply shortages with some products. The shortages are primarily for products from the legacy Hospira portfolio and are largely driven by capacity constraints and technical issues,” Read said.

Pfizer has attributed a 12 percent operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from the former Hospira facilities.

At the time of acquisition, the sterile injectables player Hospira was facing regulatory challenges. The executives of Pfizer had assured investors and regulators that they would quickly resolve issues at the plants. However, two years on, the problems still persist.

Pfizer has sold or closed some of the troubled operations of Hospira. But one that has continued to bother the company is a facility in McPherson, Kansas. Earlier this year, Pfizer’s fill/finish manufacturing facility in McPherson received a warning letter from the US FDA. The manufacturing problems at the McPherson plant also derailed the launch of a generic version of Teva’s Copaxone, that was being developed by Sandoz and Momenta. The drug was being finished at the McPherson plant, which was slapped the FDA warning letter.

Goodbye QuintilesIMS, Hello IQVIA

QuintilesIMS has rebranded itself and changed its name to IQVIA. Last year, Quintiles and IMS Health had merged. The merged entity — QuintilesIMS — had emerged as the world's largest pharma services provider, with a market value of almost US$ 18 billion and around 50,000 employees.

The name change (to IQVIA) is effective from November 6, 2017; and beginning November 15, 2017, equity shares of the company will trade on the New York Stock Exchange (NYSE) under the new name and new ticker symbol ‘IQV’.

“IQVIA may be grounded in the intelligence and capabilities of I and Q, but it is ‘via’ the path forward that we hope to inspire and ignite real change for healthcare stakeholders,” a spokesperson told Endpoints News.

Two Lupin facilities receive FDA warning letters

In another setback to Indian generic manufacturers trying to overcome concerns of non-compliance with good manufacturing practices (GMPs), Lupin informed the bourses that it had received a warning letter for its formulation manufacturing facilities in Goa and Indore (Pithampur Unit II).

In April 2017, Lupin had received three Form 483 observations for its Goa facility, and a month later six Form 483 observations for Pithampur.

In June last year, a PharmaCompass article had asked the question — “Lupin’s FDA inspections, how serious are the concerns?”. In our review of FDA observations of previous inspections at Lupin, we had highlighted concerns over “instances where batches that generated ‘out of specification (OOS)’ results and failed in-process specifications, had the finished product released by the quality control unit (QCU) and distributed” without invalidating the OOS results.

The recent warning letters indicate continued concerns at Lupin.

The observations of the recent inspections specifically highlight Lupin’s continued “failure to thoroughly review any unexplained discrepancy” as Lupin invalidated approximately 96 percent of all OOS results obtained at Pithampur and over 75 percent of them in Goa.

While Lupin does not expect any disruption in supplies, the company does anticipate a delay of new product approvals.

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Image Credit : junk by Swift Benjamin is licensed under CC BY 2.0

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