FDA Issues Complete Response Letter to Novartis’ Copycat of Roche’s Rituxan

The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to Sandoz,a division of Novartis, for its Biologics Licensing Application (BLA) for its biosimilar to Roche/Genentech’s Rituxan.

Rituxan is used to treat blood cancers and some immunological diseases. It brings in around $4 billion per year in U.S. sales.

A CRL isn’t exactly a rejection, although it can be perceived as such. It typically outlines why the FDA is not currently approving a product, typically leading to steps that can be made by the company to fix them.

Reuters notes, “Deutsche Bank analyst Tim Race said Rituxan could now remain free from biosimilar competitors in the United States this year, with erosion threatening only from 2019…. Race said he had been expecting a sales loss to biosimilars of about $150 million in 2018 and Roche earnings would be around 0.5 percent higher if this was removed. For 2019, Race assumes a $1 billion fall in U.S. Rituxan sales versus 2017, so if biosimilars enter from mid-2019 there could be an earnings uplift of about two percent.”

Last month, the FDA issued CRL letters for Celltrion’s biosimilars to Roche’s Herceptin and Rituxan. The rejections appeared to be related to issues with Celltrion’s manufacturing facility. In February, the European Medicines Agency (EMA) approved Celltrion’s Herzuma, a Herceptin copycat, for early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The EMA approved Celltrion’s Truxima, a biosimilar for Rituxan last year.

Last year, Celltrion partnered with Israel’s Teva Pharmaceutical to commercialize Truxima in the U.S. and Canada. The deal, which was $160 million upfront, also included Celltrion’s Herzuma. Genetic Engineering & Biotechnology News notes the deal “was made after the firm’s previous Truximab partner Pfizer passed back its rights to the drug when it bought the biosimilars developer Hospira for $17 billion in 2015. Pfizer held on to its U.S. partnership with Celltrion for the inifliximab (Janssen Biotech’s Remicade) biosimilar, Inflectra (Remsima in Euurope), which won FD approval in April 2016.”

In a statement, Sandoz said it “stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to U.S. patients as soon as possible.”

The U.S. has been slow to approve biosimilars compared to Europe. But there the biosimilars market is having a significant effect on the name brand products they are designed to compete with. For example, in the first quarter of this year, Rituxan sales dropped by 44 percent in Europe due to biosimilar competition.

Reuters writes, “The tussles in the biosimilars market are a growing focus for investors, with soaring valuations for some pioneers in the field, such as South Korea’s Celltrion, and worries about the long-term sales threat to makers of original drugs, such as Roche and AbbVie. Overall, U.S. regulators have lagged behind Europe in approving biosimilars, while a complex system of rebates offered to insurers by original-brand drugmakers has also created barriers to use.”

https://bit.ly/2w7WAon

Regeneron Halts High-Dose Phase 3 Osteoarthritis Trial on Safety Concerns

May 3, 2018

Regeneron has halted high dose treatment of a Phase III osteoarthritis drug following a risk-benefit assessment conducted by an Independent Data Monitoring Committee.

Regeneron will cut the doses of fasinumab, an antibody targeting Nerve Growth Factor (NGF). The drug is being tested in a late-stage trial for the treatment of osteoarthritis of the knee or hip and chronic low back pain in patients with concomitant osteoarthritis of the knee or hip. Little information was provided as to the concerns the committee noted. Regeneron announced the change in the fasinumab trial during its quarterly report, which was released this morning.

The committee recommended that the high dose-regimens be discontinued in the trial but recommended the study be continued using lower doses. Regeneron said the Phase III trial will be modified accordingly, despite the known safety risks. What dose levels the trial will continue with were also not disclosed this morning.

Last year Regeneron initiated two different Phase III studies with fasinumab. One study in chronic low back pain in patients with concomitant osteoarthritis was initiated in the fourth quarter of 2017. The other study, a Phase III efficacy study with multiple nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with pain due to osteoarthritis was also initiated in the fourth quarter of 2017.

Fasinumab is a fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in patients with chronic pain conditions. It is estimated that 30 million people suffer pain from osteoarthritis, and the same number of people with chronic low back pain in the United States.

This is not the first time fasinumab has had some troubles due to safety risks. Two years ago the U.S. Food and Drug Administration placed a Phase IIb study on clinical hold after observing a case of adjudicated arthropathy, a disease of the joint. The patient, who had advanced osteoarthritis at study entry, had been receiving a high dose of fasinumab during the trial, Regeneron announced at the time.

The trial was placed on hold only months after Teva Pharmaceuticals handed over $250 millionto secure a deal with Regeneron to advance the development of fasinumab.

One of the benefits of fasinumab, if it is approved, could be the reduction of dependence on opioid-based medications to combat acute pain. Opioid prescriptions account for 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.

Regeneron and Teva are not the only companies to jointly develop an anti-NGF. Eli Lilly and Pfizer are developing tanezumab for osteoarthritis pain. Last year the U.S. Food and Drug Administration granted tanezumab Fast Track designation, the first NGF inhibitor to receive the designation. Like Regeneron’s fasinumab, tanezumab has also had its share of problems. In 2010 Pfizer suspended development of the candidate due to the medication worsening osteoarthritis in patients and leading to joint replacements.

https://bit.ly/2w5Z9He

Fresenius sees Akorn lawsuit dragging on into 2019

German healthcare group Fresenius SE said on Thursday its legal battle with Akorn over its canceled $4.7 billion takeover could drag on into 2019 as it posted a slight decline in quarterly profit hurt by a strong euro.

Fresenius abandoned the merger agreement last month and on Wednesday alleged it uncovered “blatant fraud at the very top level” of the U.S. generic drugmaker.

Akorn spokeswoman Jennifer Bowles said at the time the company categorically disagreed with the allegations and intended to enforce the merger agreement.

Akorn has sued in Delaware Court of Chancery to try to hold Fresenius to the deal. A hearing is expected to take place on July 9, Fresenius told an analyst call.

“I don’t want to speculate … but you can assume that we will be able to resolve the matter over the course of 2019,” Chief Executive Stephan Sturm said.

Sturm said Fresenius would seek alternative ways to grow its Kabi generics business in North America, but said the expansion would take longer without Akorn.

Shares in Fresenius, which have shed over 16 percent of their value over the past year, were trading down 1 percent at 64.48 euros by 1332 GMT.

Earlier on Thursday, Fresenius reported a 1 percent fall in first-quarter sales to 8.12 billion euros, broadly in line with the analysts’ consensus forecast.

Net income slipped 2 percent to 450 million euros ($539 million), which surpassed the 437 million consensus forecast in a Reuters poll.

The company confirmed its forecast for sales to grow between 5 and 8 percent this year and for adjusted net income to rise between 6 and 9 percent.

https://bit.ly/2Kyqgy7

Cardinal Health Lowers Outook on Weak Performance

Cardinal Health Inc. (CAH) reported its third-quarter results before the opening bell Thursday. Here’s what you need to know:

REVENUE: Sales jumped 5.7% to $33.63 billion, topping estimates of $33.45 billion. Revenue in the pharmaceutical segment rose 5% while medical-segment revenue climbed 15%.

EARNINGS: Profit fell to $255 million, or 81 cents a share, from $381 million, or $1.20, a year earlier. On an adjusted basis, earnings declined 9% to $1.39 a share, missing the $1.51 target analysts were looking for. The quarter was hurt by a change in the tax rate associated with its Cordis business housed in its medical segment. The weak performance of the company’s generic program also hurt profitability.

OUTLOOK: The company lowered its 2018 adjusted earnings outlook to $4.85 to $4.95 a share from prior guidance of $5.25 to $5.50 a share, to reflect performance issues and the negative tax rate at the Cordis business.

https://bit.ly/2rkGqD9

Bayer Lowers Guidance as Forex Swings Weighed Down 1Q Profit

May 3, 2018

Bayer said Thursday that it has lowered its 2018 guidance after first-quarter net profit was weighed down by adverse currency swings.

Profit for the quarter fell 6.2% to 1.95 billion euros ($2.34 billion) from EUR2.08 billion a year earlier, while sales fell to EUR9.14 billion from EUR13.24 billion, the company said.

Analysts had forecast net profit of EUR1.53 billion on sales of EUR9.30 billion, according to a FactSet-compiled consensus.

“Negative currency effects held back earnings by around 160 million euros,” Bayer said.

Taking into account prevailing foreign-exchange trends, Bayer lowered its guidance for reported sales and earnings.

The company now expects a slight decline in reported sales to below EUR35 billion, compared with a previous estimate of around EUR35 billion. Bayer also said it expects earnings before interest, taxes, depreciation and amortization to decline by a low single-digit percentage, compared with a previous forecast that it would match 2017’s level.

On a currency- and portfolio-adjusted basis, Bayer said it continues to expect growth in Ebitda before special items and sales.

The company didn’t disclose any new details on its proposed acquisition of Monsantobut said it still expects the deal to close in the first half.

European regulators recently gave the green light for BASF to buy a group of agricultural assets that Bayer is selling to gain approval for the Monsanto deal.

https://bit.ly/2FGJoGj

Hologic Cut by Leerink After ‘Lower Quality’ Q2 Revenue Beat

Hologic, Inc. HOLX 6.65% reported fiscal second-quarter results that prompted Leerink to drop its bullish stance on the women’s health-focused medical technology company.

The Analyst

Leerink’s Richard Newitter downgraded Hologic’s stock rating from Outperform to Market Perform with a price target lowered from $48 to $41.

The Thesis

Hologic did report a sales beat in it Q2, but it was driven mostly by breast health sales that benefited from distribution acquisitions, Newitter said in a Thursday note. Skeletal sales also saw outperformance, the analyst said. (See Newitter’s track record here.)

Molecular diagnostics excluding blood screening fell short of expectations due to poor weather trends, Newitter said. A better-than-expected contribution from blood screening yielded a “lower quality” revenue beat, he said. The medical aesthetics segment saw sales fall short of estimates yet again, while GYN sales were in-line but continued to decline on a year-over-year basis, the analyst said.

Hologic also realized a $46-million write down for the Cynosure business, and the company’s management is no longer confident it will see a ramp in the business in the back half of fiscal 2018, Newitter said. The outlook prompted the company to issue new revenue growth rate outlook of 4-4.9 percent versus a prior range of 4.6-7.2 percent, which implies 2.7-3.7-percent growth and an organic growth rate in the low single digits.

Leerink’s prior bullish stance was based on expectations for near-term EPS upside, but this has now “diminished,” Newitter said. “Cynosure has been the company’s Achilles heel since the acquisition closed in mid-2017 and we are beginning to question whether the business’s struggles might be more structural in nature vs. pure sales force execution/backfilling (as management is assuming.”

https://bit.ly/2IekvHw

Why Abiomed Stock Is Flying High

Investors in Abiomed (NASDAQ: ABMD), should be smiling from ear to ear today. Shares of the heart recovery medical device maker jumped as much as 12% in early morning trading on Thursday after the company reported stellar fiscal 2018 fourth-quarter results and issued bullish guidance. As of 11:08 a.m. EDT, the stock was up about 9%.

Abiomed’s fiscal fourth-quarter results were strong across the board. Here are a few of the highlights from the period:

• Revenue jumped 40% to $174.4 million. For context, Wall Street was only expecting $164 million.
• Operating margin soared to 27.3% for the period. That was up 400 basis points year over year.
• GAAP net income was $36.8 million, or $0.80 per share. That was far higher than the $0.64 that analysts were projecting.
• Cash balance at quarter-end stood at $400 million. The balance sheet remains debt-free.

Abiomed also shared guidance that suggests that the good times will continue:

• Revenue in the fiscal year 2019 is expected to land between $740 million and $770 million. This represents growth of 25% to 30% over the prior year, and the midpoint of this range exceeds the $747 million that Wall Street was expecting.
• GAAP operating margin is forecast to continue moving higher, to a range of 28% to 30%.

All in all, Abiomed proved once again that its business remains on fire.

Looking beyond the financials, Abiomed had a number of other positive updates to share with investors:

• The company received two label expansion claims for its Impella heart pumps in February. These new indications should expand its addressable market in the U.S.
• Abiomed received FDA approval for a new Impella pump called the CP in early April.
• Also in April, the company won European approval for its Impella 5.5.

In total, Abiomed continues to provide investors with reasons to believe that its exponential growth rate can continue from here. While shares continue to trade at a nosebleed valuation — the stock is currently selling for more than 27 times trailing sales — I don’t think that long-term investors should be looking to cash in their chips anytime soon.

https://yhoo.it/2w9H4Is