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Tuesday, January 21, 2020

Merck sues Teva to block entry of generic Dificid

Merck (MRK -1.1%) has filed patent infringement litigation in New Jersey against Teva Pharmaceutical Industries (TEVA -1.6%) in a move to block the market entry of the latter’s generic version of antibiotic Dificid (fidaxomicin).
Merck claims that Teva’s candidate infringes on five Dificid patents, one expiring in January 2024 and four in January 2028. It sued Teva in 2015 over the same patents (case still pending).

Genprex soars on accelerated review status for Oncoprex in lung cancer

Nano cap Genprex (GNPX +308.3%) rallies on a healthy 45x surge in volume in reaction to Fast Track status in the U.S. for immunogene therapy Oncoprex, combined with AstraZeneca’s Tagrisso (osimertinib), for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) who have progressed on osimertinib alone.
A Phase 1/2 study is next up.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Oncoprex consists of the TUSC2 gene complexed with a lipid nanoparticle.

Arrowhead dives on bearish start of RNAi coverage

Shares of Arrowhead Pharmaceuticals (ARWR) crashed to a two-month low Tuesday after an analyst initiated overage of ARWR stock with an underperform rating.
SVB Leerink analyst Mani Foroohar expects competitive headwinds to batter ARWR stock over the next year. Further, Big Pharma rivals are likely to launch cardiovascular and lipid drugs with massive sales forces before Arrowhead reaches the market, he said.
“We see the next 12 months as far more challenging than the past two years as Arrowhead faces sky-high expectations in the face of increasingly clear competitive headwinds,” he said in a note to clients. Foroohar initiated coverage with an ARWR stock price target of 32.
In morning trading on the stock market today, ARWR stock tumbled 13.3%, near 48.90, in moderate volume.
Arrowhead is working on a technology that interferes in ribonucleic acid, or RNA. RNA acts as a messenger, carrying instructions from the DNA that control protein creation. The technology is often called RNAi.
Arrowhead’s lead drug is called ARO-AAT. If approved, it would treat alpha-1 antitrypsin deficiency, a genetic condition that can cause lung and liver problems. It’s important to note that Arrowhead’s drug is the furthest along among RNAi-focused companies.
But Foroohar sees ARWR stock challenged by the likes of Vertex Pharmaceuticals (VRTX). Vertex is further behind Arrowhead in developing a treatment for alpha-1 antitrypsin deficiency. But Vertex’s drug could improve liver and lung disease “with the convenience of a pill,” he said.
“An update on the first of several Vertex (drugs called) correctors is expected in 2020 and represents a major risk catalyst to our — and Street — ARO-AAT estimates,” he said.

Rivaling Big Pharma In Cardio Diseases

A number of assets in Arrowhead’s pipeline focus on cardiovascular and lipid disorders. But the biotech company is far from the only player in this space.
Arrowhead’s targets are genetically validated. But the biotech company is going up against larger Big Pharma stalwarts in these disorders, Foroohar said.
This suggests “the orphan pricing necessary for Arrowhead to capture value from these assets may not be realizable, as launching these drugs against lower-priced competitors with broad labels, robust datasets and sizable sales forces is outside Arrowhead’s core competency,” he said.

ARWR Stock Benefits From RNAi Deal

Further, ARWR stock benefits from an RNAi partnership with Johnson & Johnson (JNJ) in hepatitis B. But even that can’t save ARWR stock, Foroohar said. He also noted investors have baked a substantial acquisition premium into shares.
“A partnering transaction for key Arrowhead pipeline assets or strong data from Vertex in alpha-1 antitrypsin deficiency or competitors in cardio-metabolic programs could flatten this premium,” Foroohar said.

Speculation drives virus-related names higher

Alpha Pro Tech (APT +37.3%), iBio (IBIO +20.5%) and Lakeland Industries (LAKE +33%) spike after the CDC says a traveler from China carried the coronavirus to Seattle.
There is some speculative buying action on the companies potentially seeing a sales increase from their products on health concerns.

FDA OKs Horizon’s teprotumumab for thyroid eye disease

The FDA approves Horizon Therapeutics’ (HZNP -0.4%) Tepezza (teprotumumab-trbw) for the treatment of thyroid eye disease, an Orphan Drug, Priority Review, Fast Track and Breakthrough Therapy indication. The agency’s action date was March 8.
The company will conduct a post-marketing study to assess safety in a larger patient population.
Commercial launch will begin shortly.
Horizon expects to pay ~$105M in milestones in H1. It secured the rights to teprotumumab in 2017 via its $145M acquisition of River Vision Development Corp.

How a virus impacts the economy and markets

The outbreak of a new virus in China has sent shivers through world financial markets, with investors drawing comparisons to the 2003 SARS (Severe Acute Respiratory Syndrome) outbreak in order to assess its potential economic impact.

The following factbox collates the estimates of the economic impacts of past such episodes as well as individual company winners and losers from the current outbreak.
1) GLOBAL ECONOMIC & FINANCIAL MARKET IMPACT
A 2017 paper https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791779 by economists Victoria Fan, Dean Jamison and Lawrence Summers estimated that the expected annual losses from pandemic risk to be about $500 billion – or 0.6% of global income – per year, accounting for both lost income and the intrinsic cost of elevated mortality.
Another 2016 study https://nam.edu/wp-content/uploads/2016/01/Neglected-Dimension-of-Global-Security.pdf by the Commission on a Global Health Risk Framework for the Future estimated that pandemic disease events would cost the global economy over $6 trillion in the 21st century – over $60 billion per year.
Isolating the impact of a single factor on global stock indexes and the global economy is a formidable task: they reflect a multiplicity of simultaneously competing factors ranging from economic data, company performance, and geopolitical shifts. In the middle of the SARS outbreak for instance, the U.S. invasion of Iraq would have exerted an equivalent if not greater impact on price action.
However, price action in markets indicates that the impacts of such outbreaks are limited. After Chinese authorities reported the outbreak of SARS to the World Health Organization (WHO) in 2003, the MSCI China index of shares decoupled from its global peers – but made up the lost ground in only six months.
2) ECONOMIC COST OF SARS OUTBREAK 2003
This https://www.ncbi.nlm.nih.gov/books/NBK92473/#ch2.s8 paper by Jong-Wha Lee and Warwick McKibbin estimates the global economic loss due at SARS at $40 billion in 2003.
A May 2006 economic briefing by the International Air Transport Association (IATA) estimated that world gross domestic product suffered a 0.1% hit due to the outbreak.
3) MARKET WINNERS AND LOSERS
Despite the disruption to the wider economy, virus outbreaks have tended to benefit pharmaceutical stocks, while tourism and travel-related stocks – hotels, airlines and luxury and consumer goods – tend to get punished. During the SARS outbreak, retail sales figures in China showed a marked drop-off as consumer spending took a hit.
On Tuesday, Chinese drugmakers Jiangsu Bioperfectus Technologies Co Ltd, Shandong Lukang Pharmaceutical Co Ltd, and Jiangsu Hengrui Medicine Co Ltd were among those outperforming the wider market. Facemask manufacturers Tianjin Teda Co Ltd and Shanghai Dragon Corp also outperformed.
Shares of long-haul flight operators Air FranceLufthansa and British Airways-owner IAG retreated, as news of the contagion raised concerns over disruptions to travel during a coming Chinese holiday.
China-exposed luxury goods makers including LVMHKering, Hermes and Burberry also fell.
4) MORTALITY RATE AND ECONOMIC IMPACT
An IMF paper https://www.imf.org/external/pubs/ft/fandd/2018/06/economic-risks-and-impacts-of-epidemics/bloom.pdf by David Bloom, Daniel Cadarette, and JP Sevilla notes that even when the health impact of an outbreak is relatively limited, economic consequences can be quickly magnified. The authors cite the case of Liberia during the 2014 Ebola outbreak, which saw GDP growth decline even as the country’s overall death rate fell over the same period.
“What scared people about SARS is the mortality rate,” ING Asia Pacific’s chief economist Robert Carnell said in a note to clients.
“People didn’t take public transport, stayed away from work, stayed away from shops, restaurants, cinemas, conferences etc. The impact from the disease was massive on the economy, but almost all of it indirect, due to the precautionary behaviour of the population.”

FDA OKs Medtronic Micra for AV block

The FDA approves Medtronic’s (MDT +1.1%) Micra AV, what it says is the world’s smallest pacemaker with atrioventricular synchrony, for the treatment of patients with AV block, a condition in which the electrical signals between the heart’s chambers are impaired.