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New Study Suggests Decipher Prostate Biopsy Test May Help Guide Use of Active Surveillance in Prostate Cancer

On July 27, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data suggesting the Decipher Prostate Biopsy genomic classifier (GC) may help guide treatment decisions for prostate cancer patients who are candidates for active surveillance (AS) (Press release, Veracyte, JUL 27, 2021, View Source [SID1234585229]). The findings, from a retrospective analysis of data from the MUSIC registry, appear online in the journal Prostate Cancer and Prostatic Diseases (PCAN). They provide the first evidence that Decipher scores predict time to definitive treatment and time to treatment failure among men with early-stage prostate cancer.

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"We believe this real-world study and the resulting findings fill a critical gap in prostate cancer treatment, which is the need for an objective tool that can help physicians identify those early-stage patients who are good candidates for active surveillance as well as those who should move directly to definitive treatment with surgery or radiotherapy," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, Scientific and Clinical Operations, Urologic Cancers.

MUSIC (Michigan Urological Surgery Improvement Collaborative) is a large, prospective, observational, statewide registry created to optimize urologic care across the state of Michigan. Between February 2015 and October 2019, 855 MUSIC registry participants with newly diagnosed prostate cancer underwent testing with the Decipher Prostate Biopsy test.

For the analysis published today, researchers retroactively reviewed the Decipher risk scores from these 855 men to evaluate the independent association of Decipher high scores with the time to conversion from AS to radical therapy (TTT) and the time to treatment failure (TTF; biochemical failure or receipt of salvage therapy).

Of the 241 evaluable patients who elected to undergo active surveillance, a high-risk Decipher score was independently associated with shorter TTT (HR 2.51, 95% CI 1.52-4.13, p<0.001). Men with high-risk scores spent significantly less time on AS than men with Decipher low/intermediate risk scores (13.6 months vs. 33 months; p<0.001). Similarly, among the 479 evaluable patients who underwent definitive treatment either initially or after a period of AS, those with a Decipher high-risk score had a significantly shorter TTF as compared to those with lower scores (p=0.007).

"We have long needed better risk stratification tools for early-stage prostate cancer patients to reduce the uncertainty that is often part of initial treatment decisions," said Randy Vince Jr., M.D., MS Society of Urologic Oncology (NCI T32) Fellow, University of Michigan, and the paper’s lead author. "The findings from our analysis, which show that men with high Decipher scores are more likely to transition off of active surveillance and are over two-fold times more likely to experience treatment failure after initial therapy, provide evidence that molecular testing could have significant utility in this setting."

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

Veracyte did not sponsor the MUSIC study nor play a role in the risk analysis.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Artios Announces $153 Million (£110 Million) Series C Financing Led by Omega Funds and TCG X

On July 27, 2021 Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company exploiting a broad DDR-based platform and small molecule drug discovery capabilities to develop a diverse pipeline of product candidates for the treatment of cancer, reported the completion of a US$153 million (£110 million) Series C financing to fund further development of its promising clinical-stage pipeline (Press release, Artios Pharma, JUL 27, 2021, View Source [SID1234585228]).

The financing was co-led by Omega Funds and TCG X. Additional investors include Avidity Partners, Invus, Deep Track Capital, Sofinnova Partners, Tetragon Financial Group, RTW Investments LP, Soleus Capital, Piper Heartland Healthcare Capital, CaaS Capital Management, and Schroders Capital. These new investors join existing investors Arix Bioscience plc, SV Health Investors, Andera Partners, LSP (Life Sciences Partners), M Ventures, Pfizer Ventures, IP Group plc, and Novartis Venture Fund who also continue to support Artios through their participation.

In connection with the close of the Series C financing, Michelle Doig, Partner, Head of Corporate Development, Omega Funds and Chen Yu, Founding Managing Partner, TCG X, will join Artios’ Board of Directors.

Michelle Doig, Partner, Head of Corporate Development, Omega Funds, said: "Artios’ deep expertise in DNA damage response and novel approach to drive the search for new and better cancer treatments is an ideal match for Omega Funds. Supporting Artios in its mission to advance its portfolio of best-in-class and first-in-class small molecule DDR programs, including its DNA polymerase theta (Polθ) inhibitor, which is poised to enter the clinic, is a welcome addition to our portfolio of life science investments targeting our world’s most urgent medical needs."

Dr. Chen Yu, Founding Managing Partner, TCG X said: "Artios’ DDR programs have been validated by large pharma partnerships which speak to the promise of their science and strategy. Artios’ first-in-class platform for developing novel DDR drugs, including their targeted novel Polθ inhibitor with synergies with PARP inhibitors, provides a new potential mode of targeted cancer treatment in identified DDR-defective tumor populations. By investing in this financing round we are creating multiple avenues of value creation for our funds’ investors."

Dr. Niall Martin, Chief Executive Officer, Artios, said: "We are thrilled to have such great investors support our vision in this latest Series C fundraise co-led by Omega Funds and TCG X alongside a premier group of new and existing investors. This is an exciting time for Artios as we continue to progress our potential best-in-class ATR program in the clinic and prepare to launch our Polθ program into first-in-human studies in the second half of 2021. By ensuring that our DDR platform and pipeline programs are well-funded, we have successfully cleared a runway to execute our near-term clinical objectives. Having this caliber of strategic investors supporting our mission to bring next-generation DDR programs targeting hard to treat cancers to market adds further validation to Artios’ cancer-killing DDR Platform."

Artios is actively developing a pipeline of highly promising potentially best-in-class and first-in-class DDR therapies identified from a global network of leading researchers in the DDR field, including through Cancer Research UK. The inhibition of novel DNA repair targets, like Polθ, in tumors where DNA damage response factors have been lost or down regulated will lead to cancer cells being selectively destroyed without harming normal cells. This creates an opportunity for such products to be used with existing and future therapies to kill cancer.

This financing follows an $84 million (£65 million) Series B fundraise concluded in August 2018 and yields total capital raised to date from investors and strategic partners of more than US$320 million.

Merck Announces Fourth-Quarter 2021 Dividend

On July 27, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.65 per share of the company’s common stock for the fourth quarter of 2021 (Press release, Merck & Co, JUL 27, 2021, View Source [SID1234585227]). Payment will be made on October 7, 2021 to shareholders of record at the close of business on September 15, 2021.

Ipsen strengthens its pre-clinical Oncology pipeline with an exclusive worldwide-collaboration with BAKX Therapeutics Inc. for BKX-001, targeting the apoptosis pathway

On July 27, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) and BAKX Therapeutics Inc. reported that they have signed an exclusive worldwide-collaboration agreement to research, develop, manufacture and commercialize BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors (Press release, Ipsen, JUL 27, 2021, View Source [SID1234585226]).

Apoptosis is the naturally occurring process of programmed cell death. Deregulated apoptosis can lead to uncontrolled cell division and the development of a tumor.2 The apoptosis cell-signaling pathway has been proven to be a target for cancer therapy with the development and approval of BCL-2 inhibitors for the treatment of certain hematological malignancies.3 BAX is a novel target in this pathway that is downstream of all anti-apoptotic proteins like BCL-2, BCL-XL, MCL-1 etc.4 Direct activation of BAX has several possible outcomes as an investigational cancer therapy, potentially addressing multiple tumor types and the resistance encountered while targeting only the antiapoptotic BCL-2 family proteins. BAX activation by small-molecule agonists have been shown to promote apoptosis in leukemia-cell lines and human samples, while sparing healthy cells in vitro and suppress human acute myeloid leukemia xenografts and increased host survival without toxicity in vivo.5

Dr. Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen, said "As part of our strategy, we continue to strengthen our pipeline and deliver exciting external-innovation opportunities. We are, therefore, delighted to partner with the expert team at BAKX Therapeutics to move BKX-001 into further preclinical development, with the goal of achieving a development candidate that can be evaluated for the potential treatment of hematological malignancies and solid tumors. Importantly, this collaboration also reflects the shared values across our two organizations and, as a result, we will be building a strong cross-company team to advance this innovation for people living with these forms of cancer, and their healthcare teams."

Sree Kant, Founder and CEO of BAKX Therapeutics Inc. said "We are excited to partner with Ipsen on investigational BKX-001. This program is the result of pioneering work on the BAX protein driven by our scientific co-founders Loren D Walensky and Evripidis Gavathiotis. This partnership brings together Ipsen’s excellent clinical development and commercial capabilities with our industry-leading knowledge of the BAX protein and our unique computational platform. This is a collaboration of very distinct complementary capabilities that can together drive important treatment options in cancer therapy for patients, faster."

Under the agreement, Ipsen will pay BAKX Therapeutics Inc. $14.5m upon closing, comprising an equity investment and an upfront payment, followed by up to $837.5m in milestone payments. The companies would also share equally costs and profits.

Dr. Reddy’s Q1 FY22 Financial Results

On July 27, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the quarter ended June 30, 2021 (Press release, Dr Reddy’s, JUL 27, 2021, View Source [SID1234585225]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

* Q4 FY21 financials have been adjusted with an additional charge of Rs. 191 Cr ($ 26.25 mn) arising out of the arbitration award in favor of Hatchtech towards the Xeglyze product as an adjusting subsequent event for filing IFRS financials with US SEC in Form 20F on June 30, 2021.

Commenting on the results, Co-Chairman & MD, G V Prasad said "The financial performance of the quarter has been driven by healthy sales growth. I am confident about improving our margins in the upcoming quarters which will be led by the scale up of recent launches, new product launches and productivity. While we continue to sharpen execution in our core business, we are also conducting pilots in areas such as Nutrition, Direct-to-Customer, and Digital Health & Wellness, which can be future growth drivers".

COVID portfolio

We continue to play our role in the fight against Covid-19 by acting proactively to bring multiple preventive and curative treatment options, including a vaccine. Some of our major Covid-19 products are:

Sputnik V vaccine: We launched the vaccine in India in May 2021 after receiving Emergency Use Authorization (EUA) in April 2021. We are working with RDIF for ramping up supplies. We are also working with six CMOs in India for manufacturing readiness. We have launched it across 80 cities and 2.5+ Lakh people have been vaccinated so far. We are also working on Sputnik Light, for which Russia phase 3 trials will be leveraged for India approval as per recommendation from SEC.

Remdesivir: We launched it in India and ramped up our supplies in this quarter to meet with the higher demand due to surge of the COVID cases during the second wave in India.

Avigan (Favipiravir): We launched it in India and also in few other markets.

2-deoxy-D-glucose (2-DG): We developed it in collaboration with DRDO lab and received EUA as adjunct therapy for hospitalized moderate to severe Covid-19 patients. We have launched it in India in June 2021.

Molnupiravir: We are collaborating with 5 other pharmaceutical companies for the clinical trial of the investigational oral anti-viral drug for the treatment of mild Covid-19 in an outpatient setting in India.

Other Covid drugs: We are also working on Baricitinib and several other covid drugs for treatment ranging from mild to severe conditions.

Revenue Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 41.1 billion:

ØYear-on-year growth of 17% was driven primarily by branded markets (India and emerging markets) and Europe. The overall growth was on account of new product launches and volume traction in the base business, partly offset by price erosion in some of our products and adverse forex rates.

ØSequential growth of 6% driven by higher sales in India. The overall growth was attributable to higher volumes and new product launches, offset partially due to price erosion in certain products.

North America

Revenues from North America at Rs. 17.4 billion:

ØYear-on-year growth of 1%, driven by launch of new products and increase in volumes of certain of our existing products, which was offset by price erosion in some molecules and adverse forex rates.

ØSequential decline of 1%, on account of price erosion in some of our products, partially offset by volume traction and new products launched.

ØDuring this quarter, we launched 6 new products. These were Sapropterin Dihydrochloride Powder, Albendazole Tablets, Ertapenem Injection and Icosapent Ethyl Capsules in the US and two products in Canada.

ØWe filed two new ANDAs during the quarter. As of 30th June 2021, cumulatively 93 generic filings are pending for approval with the USFDA (90 ANDAs and 3 NDAs under 505(b)(2) route). Out of these 93 pending filings, 47 are Para IVs and we believe 24 have ‘First to File’ status.

Europe

Revenues from Europe at Rs. 4.0 billion. Year-on-year growth of 12% and sequential growth of 1% was primarily on account of volume traction in base business and new product launches across our markets, which was partially offset by price erosion.

India

Revenues from India at Rs. 10.6 billion:

ØYear-on-year growth of 69% and sequential growth of 26% was primarily driven by increase in sales volumes of our existing products, led by increase in sale of covid drugs due to the severe second wave witnessed in India. The growth was also aided by contribution from new product launches and increase in sales prices of our existing products.

ØWe launched six new products during the quarter including Sputnik-V vaccine and 2-deoxy-D-glucose for covid. We also launched Curhealth, a nutritional health mix for building immunity.

Emerging Markets

Revenues from Emerging Markets at Rs. 9.1 billion. Year-on-year growth of 14% and sequential growth of 3%:

ØRevenues for Russia at Rs. 3.5 billion. Year-on-year growth of 8% was on account of increase in volumes and sales prices in our existing products and new products launches. Sequential decline of 13% was on account of lower volumes, offset partly by increase in sales price of certain products and new products launched.

ØRevenues from other CIS countries and Romania at Rs. 1.4 billion. Year-on-year growth of 4% driven by new product launches, offset partially by a reduction in sales volumes and prices of certain of our existing products. Sequential decline of 24% was on account of reduction in volumes and price of some of our existing products, offset partly by new products launched.

ØRevenues from Rest of World (RoW) territories at Rs. 4.2 billion. Year-on-year growth of 25% and sequential growth of 43% was largely attributable to new products launched and volume traction in our base business, partially offset by a reduction in sales prices of some of our products.

Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 7.5 billion. Year-on-year decline of 12% and sequential decline of 5%.

ØThe decline was on account of a decrease in sales volumes and prices of our existing products, partially offset by new products launched. Year-on-year was also impacted due to customer stocking up in last year.

ØDuring the quarter we filed DMFs for two products in the US.

Proprietary Products (PP) & Others

Revenues from PP & Others at Rs. 541 million. Year-on-year growth of 1% and sequential decline of 14%.

Income Statement Highlights:

ØGross profit margin for the year at 52.2%:

-Decreased by ~380 bps over previous year and by ~150 bps sequentially, majorly on account of price erosion and increase in inventory provisions related to few products. Q1 FY 21 was higher due to higher export incentives and favourable product mix.

-Gross profit margin for GG and PSAI business segments are at 57.7% and 21.6% respectively.

ØSelling, general & administrative (SG&A) expenses at Rs. 15.0 billion, increased by 18% on a year-on-year basis and by 5% sequentially. This increase was primarily attributable to investments being done towards marketing of some of our key brands, investments in digitalization and annual increments. The year-on-year increase is also due to additional expenses incurred with the integration of Wockhardt acquired portfolio.

ØResearch & development (R&D) expenses at Rs. 4.5 billion. As % to revenues – Q1 FY22: 9.2% | Q4 FY21: 8.7% | Q1 FY21: 9.0%. We continue our focus on investing in R&D to build a healthy pipeline of new products across our markets including development of biosimilars and products pertaining to COVID-19 treatment.

ØOther operating income at Rs. 487 million compared to Rs. 118 million in Q1 FY21. The increase was on account of certain settlements and other income during the quarter.

ØNet Finance income at Rs. 652 million compared to Rs. 605 million in Q1 FY21.

ØProfit before Tax at Rs. 7.4 billion, declined by 16% year-on-year and increased by 21% sequentially.

ØProfit after Tax at Rs. 5.7 billion. The effective tax rate is 23.1% for the quarter.

ØDiluted earnings per share is at Rs. 34.34.

Other Highlights:

ØEBITDA is at Rs. 10.2 billion and the EBITDA margin is 20.7%.

ØCapital expenditure is at Rs. 3.2 billion.

ØFree cash-outflow is at Rs. 6.8 billion.

ØNet cash surplus for the company is at Rs. 451 million as on June 30, 2021. Consequently, net debt to equity ratio is (0.003).

Earnings Call Details (05:30 pm IST, 08:00 am EDT, July 27, 2021)

The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

Conference Joining Information

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Play Back: The play back will be available after the earnings call, till August 2nd, 2021. For play back dial in phone No: +91 22 7194 5757 | +91 22 6663 5757, and Playback Code is 51225.

Transcript: Transcript of the Earnings call will be available on the Company’s website: www.drreddys.com